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Filings & Releases — September 2026

742 documents from 226 companies (428 releases) · updated Nov 7, 2026

Company

All filings (+94)

Wednesday, September 3039

ZURAZura BioS-8Employee plan registration
WVEWave Life SciencesReleaseWave Life Sciences Announces GSK’s Selection of siRNA program to Transition to GSK for Further Development
VRCAVerrica PharmaceuticalsReleaseVerrica Pharmaceuticals to Present New YCANTH® Data Analysis at Two Upcoming Dermatology ConferencesBD extracted 2 program updates from this document → VRCA pipeline
TLXTelix Pharmaceuticals6-KForeign issuer report · EX-99
TLSATiziana Life Sciences6-KForeign issuer report · EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 30, 2026
STOKStoke TherapeuticsSCHEDULE 13GPassive >5% holder (13G)
SRPTSarepta TherapeuticsReleaseSarepta Therapeutics Presents New Data at 2026 World Muscle Society Annual Congress Demonstrating Safety and Clinically Meaningful Functional Benefit of ELEVIDYS (delandistrogene moxeparvovec) in OldeBD extracted 1 program update from this document → SRPT pipeline
SGMTSagimet BiosciencesReleaseSagimet Announces Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne Presented at EADV 2026 → BD updateSummary on the 8-K
SGMTSagimet BiosciencesReleaseSagimet Biosciences Announces Pricing of $115.0 Million Underwritten Offering of Series A Common Stock and Pre-Funded Warrants → BD updateSummary on the 8-K
SGMTSagimet Biosciences8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe full 52-week OLE data from Ascletis' ASC40-304 are in — ~57% IGA success, ~75-80% lesion reduction, no safety surprises — and Sagimet simultaneously priced a $115M offering today, with AURORA patient screening starting October.BD extracted 1 program update from this document → SGMT pipeline
SGMTSagimet Biosciences424B3Prospectus (resale / update)→ BD updateSummary on the 8-K
QTTBQ32 BioReleaseQ32 Bio Presents Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata in a Late-Breaker at the European Academy of Dermatology and Venereology Congress 2026 → BD updateSummary on the 8-K
QTTBQ32 Bio8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateToday's EADV late-breaker delivered the durability numbers and JAK-subgroup split the thesis was waiting on — and the results are genuinely mixed: robust off-drug maintenance for responders, but JAK non-responders averaged only 4.8% SALT reduction, a figure that cuts hard against the "differentiated for JAK failures" commercial story.BD extracted 1 program update from this document → QTTB pipeline
PMNProMIS NeurosciencesReleaseUpcoming Conferences and Events in October
OTLKOutlook Therapeutics8-KCurrent report: listing noticeOTLK just received a formal Nasdaq deficiency notice — 30 consecutive sessions below $1.00 — giving it until March 24, 2027 to regain compliance, a deadline that now collides with the Atlas note maturity and management's own stated runway end.
OCSOculis HoldingReleaseOculis Announces Resignation of Lionel Carnot from Board of Directors
OCSOculis Holding6-KForeign issuer report · EX-99.1
OCGNOcugenReleaseOcugen to Participate in Upcoming Scientific Conferences
NRXPNRX PharmaceuticalsReleaseNRx Defense Systems, an NRx Company (Nasdaq:NRXP) Awarded $11 Million Dollar DARPA Prime Contract to Evaluate Robotic Magnetic Stimulation in conjunction with NRX-101 for Treatment of Resistant Depres → BD update
NKTRNektar TherapeuticsReleaseNew Biomarker Data Presented in a Late Breaking Oral Presentation at EADV Congress 2026 Showing Early Molecular Responses to Rezpegaldesleukin Across Multiple Immune Pathways Dysregulated in PatientsRezpeg's EADV late-breaker shows FOXP3 upregulation and multi-pathway immune normalization as early as Week 2, with early biomarker changes significantly predicting Week-16 clinical response (p<0.001) — the strongest mechanistic linkage yet published, landing precisely where I said KOL reception would matter most.BD extracted 1 program update from this document → NKTR pipeline
MLTXMoonLake Immunotherapeutics8-KCurrent report: other eventsMoonLake filed the HS BLA today — the exact submission I flagged as the September catalyst — while the stock sits 29.5% below the August 11 close. The clock to the late-November acceptance print (the real unlock) is now running.
LQDALiquidiaReleaseLiquidia Provides Update on Hatch-Waxman Litigation Tied to ‘327 Patentvia aggregator
LQDALiquidia8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1
LGVNLongeveronReleaseLongeveron to Participate in Three Longevity/Aging Investment Conferences
KODKodiak SciencesSCHEDULE 13D/A13D amendment → BD updateTwo days after DAYBREAK vindicated the Franken-formulation, Baker Bros. filed a 13D/A disclosing they bought more shares — lifting their stake to 35.0% — the clearest vote of confidence yet from the fund that anchored Kodiak's turnaround.
JBIOJade BiosciencesReleaseSEPTEMBER 30, 2026 Jade Biosciences Announces Preclinical Data Characterizing JADE301, a Potentially Best-in-Class, Half-Life-Extended Anti-IFN-B Monoclonal Antibody in Development for Dermatomyositis → BD updateSummary on the 8-K
JBIOJade Biosciences8-KCurrent report: other events → BD updateJADE301's EADV preclinical data landed this morning with a 25-day NHP half-life, ~73-75% predicted human SC bioavailability, and 8x potency over the dazukibart comparator — but the stock is at $14.05, down 35% from the August close, and the reaction needs decoding.
INKTMiNK TherapeuticsReleaseMiNK Therapeutics Selected for ARPA-H-Funded Initiative to Advance Room-Temperature Cell TherapyMiNK's iNKT manufacturing platform just got selected for an ARPA-H-funded biostabilization program — non-dilutive government validation of the one moat I've consistently called underappreciated, arriving while subscribers wait for the early-2027 ARDS readout.
IMNMImmunomeReleaseImmunome Announces IND Clearance for IM-1340, a Potential First-in-Class Antibody-Drug Conjugate for the Treatment of Solid Tumorsvia aggregator
IMMXImmix BiopharmaReleaseImmix Biopharma Announces Closing of $125 Million Underwritten Offering of Common Stock
IMMXImmix Biopharma8-KCurrent report: other events · EX-99.1
HROWHarrowReleaseHarrow Ophthalmic Portfolio Highlighted in 15 Scientific Presentations at AAOpt and AAO
GLUEMonte Rosa TherapeuticsReleaseMonte Rosa Therapeutics to Present Results of MRT-8102 GFORCE-1 Phase 1 Study in Subjects with Elevated Cardiovascular Disease RiskThe GFORCE-1 full readout drops tomorrow morning (October 1, 8am ET) — the calprotectin/DAMP data I've flagged as the key differentiator between "oral canakinumab" and something genuinely superior finally gets its day, while the stock has quietly bled another 16% since the September update.BD extracted 1 program update from this document → GLUE pipeline
DBVTDBV Technologies8-KCurrent report: other events · EX-99.1 → BD update
CRVSCorvus PharmaceuticalsReleaseCorvus Pharmaceuticals Announces Initiation of Phase 1b Clinical Trial of Soquelitinib for Patients with Hidradenitis SuppurativaBD extracted 1 program update from this document → CRVS pipeline
CNTBConnect BiopharmaReleaseConnect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adults with COPD and Type 2 Inflammation → BD updateSummary on the 8-K
CNTBConnect Biopharma8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateSeabreeze STAT COPD hit — rademikibart cut treatment failure 81% (p=0.0122) and eliminated all hospital/ED returns — delivering the clean primary endpoint the asthma trial couldn't generate two weeks ago, while the key FEV₁ secondary missed and the financing clock keeps ticking.BD extracted 1 program update from this document → CNTB pipeline
CMPSCOMPASS PathwaysReleaseCompass Pathways Appoints Kelley Boucher as Chief People Officer
CMMBChemomab Therapeutics6-KForeign issuer reportCMMB has collapsed 45% in five trading days to $1.19 — implying a combined-company value of ~$37M, now well below even the PIPE warrant strike. A procedural merger amendment filed after today's close confirms the deal is still alive, but the tape is pricing it like it isn't.
ARDXArdelyxReleaseArdelyx Earns Multiple Honors at the 2026 PM360 Trailblazer Awards
ALLOAllogene TherapeuticsSCHEDULE 13D/A13D amendment → BD updateTPG liquidated its entire ALLO position — 18.7 million shares sold at $1.55 on September 28 — going from a founding-era 13D holder to zero, at a price below the April offering and not yet reflected in the regular session close.

Tuesday, September 2941

VORVor BiopharmaReleaseTelitacicept Demonstrates Deep and Durable Minimal Symptom Expression Through 48 Weeks in Generalized Myasthenia GravisA post hoc 48-week analysis from RemeGen's Chinese Phase 3 shows 94%+ of gMG patients hitting ≥5-point MG-ADL improvement and 86.7% of minimal-symptom responses sustained month-to-month — yet the stock has shed 27% since enrollment closed three weeks ago, a disconnect that demands decoding.BD extracted 1 program update from this document → VOR pipeline
VNDAVanda PharmaceuticalsReleaseVanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disordervia aggregator
UNCYUnicycive TherapeuticsReleaseUnicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate → BD updateSummary on the 8-K
UNCYUnicycive Therapeutics8-KCurrent report: officer / director change, other events · EX-99.1 PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED SEPTEMBER 29, 2026 → BD updateUnicycive just resubmitted the OLC NDA — not by fixing the broken factory, but by replacing it entirely with a vendor that already carries a clean FDA inspection record and 12-month stability data. That's a materially different approval path than the one I said to avoid.
TECXTectonic TherapeuticReleaseU.S. FDA has granted Fast Track designation for TX2100 in HHT and cleared the Investigational New Drug (IND) application for the TX2100 Phase 1b clinical trial in HHT patients in the U.S. TX2100 Phase → BD updateSummary on the 8-K
TECXTectonic Therapeutic8-KCurrent report: other events · EX-99.1 → BD updateTX2100 cleared its Phase 1a safety bar across all six dose cohorts with no serious adverse events, the FDA granted Fast Track Designation for HHT and cleared the Phase 1b IND — and the lottery ticket is now officially heading into patients by year-end 2026 alongside a parallel Phase 2 in early 2027.BD extracted 1 program update from this document → TECX pipeline
STROSutro BiopharmaReleaseSutro Biopharma Appoints Lucas Donigian as Senior Vice President, Business Developmentvia aggregator
SMMTSummit Therapeutics8-KCurrent report: material agreement, unregistered sale of equity, charter / bylaws / fiscal year · EX-99.1 → BD updateAstraZeneca just wrote a $2 billion check at $18.36/share — a premium to market — and signed a clinical collaboration on Claudin 18.2 ADC combinations with ivonescimab. The going-concern overhang that haunted this name since May is now functionally dead, and a top-tier pharma oncology team has put its balance sheet behind the same data the FDA will rule on in 47 days.
RNACCartesian TherapeuticsReleaseCartesian Therapeutics Announces Additional Retreatment Data for Descartes-08 Highlighting Deep and Durable Responses in Patients with Myasthenia Gravis → BD updateSummary on the 8-K
RNACCartesian Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateCartesian's retreatment data in five Phase 2 MG patients shows Descartes-08 not only works on the second course — it works better, with a 6.6-point MG-ADL reduction sustained through Month 12 and zero serious adverse events — answering the durability question that has hung over the bull case while the stock sits 17% below the August peak.BD extracted 1 program update from this document → RNAC pipeline
QUREuniQureReleaseuniQure Announces Additional Data from Ongoing Phase I/II Studies of ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease Showing Continued Slowing of Disease Progressionvia aggregator→ BD updateSummary on the 8-K
QUREuniQure8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1 → BD updateThe four-year AMT-130 data the thesis has been riding on just landed — and the primary endpoint at 48 months missed statistical significance (44% cUHDRS slowing, p=0.144), sending the stock into a 47% crash from its September 2 close, even as TFC held better and a post-hoc analysis argues the external control is biased toward under-estimating the treatment effect.BD extracted 1 program update from this document → QURE pipeline
ONCYOncolytics BiotechReleaseOncolytics Biotech® Announces Publication Demonstrating Pelareorep Creates Immune Responses in Liver Cancer That Make Tumors Susceptible to Immunotherapy
ONCYOncolytics Biotech8-KCurrent report: other events · EX-99.1
OCGNOcugenReleaseOcugen to Participate in Upcoming October Investor and Industry Conferences
NRIXNurix TherapeuticsReleaseNurix Therapeutics Announces Achievement of $7 Million Milestone Under Strategic Collaboration with Pfizer
NAMSNewAmsterdam PharmaReleaseNewAmsterdam Pharma Doses First Participant in Phase 2b SPINOZA Trial Evaluating Obicetrapib in Preclinical Alzheimer’s DiseaseSummary on the 8-K
NAMSNewAmsterdam Pharma8-KCurrent report: other events · EX-99.1NAMS dosed the first participant in SPINOZA today — a randomized, double-blind, placebo-controlled Phase 2b trial of obicetrapib in ~400 preclinical Alzheimer's patients — converting the Alzheimer's program from a biomarker sub-study into an actual controlled trial, though the thesis remains anchored to PREVAIL's Q1 2027 DSMB readout.
MBRXMoleculin BiotechReleaseMoleculin Biotech Completes Enrollment in Part A of Phase 2/3 R/R AML MIRACLE Trial, Keeping Program on Track for Q1 2027 Data Readout → BD updateSummary on the 8-K
MBRXMoleculin Biotech8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1 → BD updateMIRACLE Part A enrollment is closed at n=89 and the Q1 2027 data readout is confirmed — but the CEO just disclosed the final population shifted from 70/30 fit/unfit to ~50/50, meaning the decisive binary will be run against a meaningfully harder patient mix than the first interim.BD extracted 1 program update from this document → MBRX pipeline
LXEOLexeo Therapeutics8-KCurrent report: acquisition / disposition, unregistered sale of equity
LRMRLarimar TherapeuticsReleaseLarimar Therapeutics Strengthens Executive Leadership with Appointment of John Harlow as President and Chief Operating OfficerSummary on the 8-K
LRMRLarimar Therapeutics8-KCurrent report: officer / director changeLarimar just hired a President & COO whose entire career is building commercial infrastructure at specialty pharma companies — a direct signal that management is treating a mid-2027 launch as a probability, not a hope.
KURAKura OncologyReleaseCaspian Therapeutics Unveils KO-7246 at EASD as a Potential Best-In-Class Menin Inhibitor for Diabetes
KROSKeros Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1
IVVDInvivydReleaseInvivyd Announces Positive Topline Results from LIBERTY Phase 3 Study Demonstrating VYD2311 Safety and Tolerability Superior to mRNA-based COVID-19 Vaccine; Announces Regulatory Submission Plans for V → BD updateSummary on the 8-K
IVVDInvivyd8-KCurrent report: other events · EX-99.1 → BD updateLIBERTY hit every endpoint — VYD2311 beat the mRNA vaccine on safety (56.5% vs. 91.4% TEAE rate, p<0.0001) and produced no hypersensitivity — and Invivyd announced a Type C FDA meeting outcome pointing to an Accelerated Approval BLA path with DECLARATION sVNA data due in October. The stock fell 16.7% anyway, pricing in the gap between a tolerability win and the actual efficacy binary that still lies ahead.BD extracted 1 program update from this document → IVVD pipeline
IMMXImmix BiopharmaReleaseImmix Biopharma Announces 89% Complete Response Rate at Interim Update Across All NEXICART-2 Patients, with MRD-Negativity Indicating Potential to Reach up to 98% Complete Response Rate, Supporting Po → BD updateSummary on the 8-K
IMMXImmix BiopharmaReleaseImmix Biopharma Announces Pricing of $125 Million Underwritten Offering of Common Stock → BD updateSummary on the 8-K
IMMXImmix BiopharmaFWPFree writing prospectus (offering terms)→ BD updateSummary on the 8-K
IMMXImmix Biopharma8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateToday's NEXICART-2 interim data across all 45 patients printed an 89% CR rate — with 4 MRD-negative patients pointing toward 98% — while Immix simultaneously priced a $125M offering at $11.00/share via J.P. Morgan, fortifying the balance sheet but adding another 11.4M shares ahead of the mid-2027 final readout.
IMMXImmix Biopharma424B5Prospectus supplement (offering)→ BD updateSummary on the 8-K
GANXGain TherapeuticsReleaseGain Therapeutics Announces Poster Presentation at International Congress of Parkinson’s Disease and Movement Disordersvia aggregator
DYNDyne TherapeuticsReleaseDyne Therapeutics Announces Additional One-Year Clinical Data from Phase 1/2 ACHIEVE Trial of Z-Basivarsen (DYNE-101) for Myotonic Dystrophy Type 1 (DM1)→ BD updateSummary on the 8-K
DYNDyne Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateZ-basivarsen's 12-month ACHIEVE data just got materially stronger — a larger pooled cohort (N=26) now shows divergence from matched natural history across strength, function, and patient-reported outcomes, and the registrational cohort's baseline vHOT of 8.3 seconds lines up almost exactly with where the MAD data showed the drug's biggest effect. With DYN down ~35% since late July, this data is the bull case's answer.BD extracted 1 program update from this document → DYN pipeline
DBVTDBV TechnologiesReleaseDBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years
CLRBCellectar BiosciencesReleaseCellectar Biosciences to Present Compelling Efficacy Data from Phase 2 CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Refractory/Resistant to BTK Inhibitor Therapy at International WorkshoBD extracted 1 program update from this document → CLRB pipeline
CGTXCognition TherapeuticsReleaseCognition Therapeutics Schedules a Type C Meeting with FDA to Align on Endpoints for Phase 3 Trial of Zervimesine (CT1812) in DLB → BD updateThe single open regulatory item that's been blocking the Phase 3 start just got a date: October 20, Cognition meets with the FDA Division of Neurology to nail down the NPI endpoint statistics for the DLB psychosis registrational trial — the last formal gate before the trial clock starts.
ALTAltimmune8-KCurrent report: officer / director change
ALDXAldeyra TherapeuticsReleaseAldeyra Therapeutics Announces Intent to Submit Formal Dispute Resolution Request for Reproxalap to Treat Dry Eye Disease → BD updateSummary on the 8-K
ALDXAldeyra Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateAfter a September 25 Type D meeting that failed to converge with the FDA review division, Aldeyra is escalating to a Formal Dispute Resolution Request — appealing the March CRL to the Office of New Drugs itself — while extending cash runway to 2029 and publishing the most detailed public data defense of reproxalap yet.BD extracted 1 program update from this document → ALDX pipeline

Monday, September 2842

ZYMEZymeworksReleaseZymeworks Announces Updated 2026 Financial Guidance and Final Transaction Details Following Theravance Biopharma Acquisitionvia aggregatorZymeworks dropped updated 2026 financial guidance this morning alongside the first post-Theravance-close transaction details — exactly the combined-company cash picture the last update told subscribers to watch for.
VSTMVerastemReleaseVerastem Oncology Announces Publication in Gynecologic Oncology of Two-Year Median Follow-Up Data from RAMP 201 Study of AVMAPKI® FAKZYNJA® CO-PACK (avutometinib capsules; defactinib tablets) in RecurBD extracted 1 program update from this document → VSTM pipeline
VKTXViking TherapeuticsReleaseViking Therapeutics Announces Closing of Concurrent Upsized Offerings of Common Stock and Convertible Senior Notes, Including Full Exercise of Underwriters' Options to Purchase Additional Shares of CoSummary on the 8-K
VKTXViking Therapeutics8-KCurrent report: material agreement, debt / obligationViking just closed its dual offering at $575M gross — every share and every dollar of convertible debt was snapped up, both greenshoes exercised in full, locking in ~$547.8M net and potentially extending runway to late 2028. The tank is refilled; the dilution gap I've been tracking since April is now closed.
UNCYUnicycive Therapeutics8-KCurrent report: other events
TLSATiziana Life Sciences6-KForeign issuer report · EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 28, 2026
SMMTSummit TherapeuticsReleaseAstraZeneca Makes $2 Billion Strategic Equity Investment in Summit Therapeutics → BD updateAstraZeneca just wrote a $2 billion check for Summit at $18.36/share — a 19% premium to today's close — validating the ivonescimab thesis in the strongest possible currency, 47 days before the FDA's decision.
SGMTSagimet BiosciencesReleaseSagimet Biosciences to Host Virtual KOL Event, “Denifanstat Update: 52-Week Data from Phase 3 Open-Label Extension in China and Planned AURORA Phase 3 Clinical Trial in US” on September 30, 2026BD extracted 1 program update from this document → SGMT pipeline
SCYXScynexisReleaseSCYNEXIS Awarded BARDA Contract Providing Up to $214 Million in Non-Dilutive Funding for the Development of SCY-247 → BD updateSummary on the 8-K
SCYXScynexis8-KCurrent report: material agreement, Reg FD disclosure · EX-99.1 → BD updateBARDA just handed SCYNEXIS up to $214M in non-dilutive funding to advance SCY-247 — the antifungal asset I called "optionality, not a value driver, until a partner or grant appears." The grant appears.
RCUSArcus BiosciencesCT ORDERCT ORDERGilead quietly filed a 13D/A amendment on August 7 — the same day it surrendered its board seats — and just won confidential treatment for a redacted exhibit. The SEC's Office of Mergers and Acquisitions signed off. That's not nothing.
PTNPalatin TechnologiesReleasePalatin Reports Fiscal Year 2026 Financial Results and Provides Business Update → BD updateSummary on the 10-KBD extracted 1 program update from this document → PTN pipeline
PTNPalatin Technologies10-KAnnual report → BD updateThe FY2026 10-K confirms $7.5M cash, a going-concern warning, and another IND slip — but also names the PL1000/PL2000 peptide series for the first time, partially addressing the "unnamed candidate" problem. The Series J warrant clock is now critically short.
PHIOPhio PharmaceuticalsS-8Employee plan registration
PHIOPhio Pharmaceuticals8-KCurrent report: officer / director change, shareholder vote
PALIPalisade BioReleasePalisade Bio to Present Clinical and Translational Data for PALI-2108 in Ulcerative Colitis and Crohn’s Disease at UEG Week 2026via aggregator
ONCYOncolytics BiotechReleaseOncolytics Biotech® Reports Accelerating Enrollment in Randomized REO 033 RAS-Mutant, MSS Colorectal Cancer Study
ONCYOncolytics Biotech8-KCurrent report: other events · EX-99.1
NRSNNeuroSense TherapeuticsReleaseNeuroSense to Participate in the 5th Annual ROTH Healthcare Opportunities Conference
NKTRNektar TherapeuticsSCHEDULE 13G/A13G amendment
NKTRNektar TherapeuticsReleaseNektar Announces Three Oral Presentations for Rezpegaldesleukin at the European Academy of Dermatology & Venereology (EADV) Congress 2026BD extracted 1 program update from this document → NKTR pipeline
MBRXMoleculin BiotechReleaseMoleculin Announces Publication of Peer-Reviewed Cardiac Safety Analysis of Annamycin in Frontiers in Cardiovascular Medicine
MBRXMoleculin Biotech8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → MBRX pipeline
KROSKeros Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1
KODKodiak SciencesReleaseZenkuda and tabirafusp-ted Meet Primary Endpoints in Pivotal DAYBREAK Trial in wAMD, with Zenkuda Demonstrating a Potential New Standard-of-Care Profile with Strong Immediacy and Sustained Clinical Ef → BD updateSummary on the 8-K
KODKodiak Sciences8-KCurrent report: other events · EX-99.1 → BD updateDAYBREAK delivered a clean sweep: Zenkuda and tabirafusp-ted both hit primary endpoints in wet AMD, with 54% of Zenkuda patients on 6-month dosing and a near-zero inflammation signal — the Franken-formulation has now won three Phase 3s in a row, and a BLA is coming in Q4.BD extracted 2 program updates from this document → KOD pipeline
INBXInhibrx Biosciences8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 2 program updates from this document → INBX pipeline
IMRXImmuneeringReleaseImmuneering Presents Data at 2026 AACR Conference on Pancreatic Cancer Supporting Atebimetinib’s Mechanisms Designed to Extend Survival in Pancreatic CancerBD extracted 1 program update from this document → IMRX pipeline
IDYAIDEAYA BiosciencesReleaseIDEAYA Biosciences Announces the Promotion of Dr. Michael White to President, Research and Development
GOSSGossamer BioSCHEDULE 13D/A13D amendment
GOSSGossamer Bio8-KCurrent report: other events
GANXGain Therapeutics8-KCurrent report: officer / director change → BD updateGANX's CFO just resigned, effective September 30 — leaving CEO Gene Mack as interim CFO, principal financial officer, and principal accounting officer simultaneously, just weeks before the make-or-break October Phase 1b readout and with going-concern language still on the books.
FDMT4D Molecular TherapeuticsRelease4DMT Advances 4D-150 into Phase 3 for Second Large Market Retina Indication with Initiation of 4SIGHT in DME → BD updateSummary on the 8-KBD extracted 2 program updates from this document → FDMT pipeline
FDMT4D Molecular Therapeutics8-KCurrent report: other events → BD update4SIGHT Phase 3 DME trial is enrolling (N=514, larger than the ~300–400 I'd guided to), and SPECTRA 2-year data extend the durability story — but the numbers require careful reading before the stock's 25% run looks justified.
FATEFate Therapeutics8-KCurrent report: other events · EX-99.1CIRM's peer-reviewed $15M CLIN2 grant to RECLAIM-LN is non-dilutive capital that buys runway and carries a third-party scientific endorsement — a modest but real dent in the two bear-case pillars I named: the dilution gap and credibility of the single-arm design.
ETONEton PharmaceuticalsReleaseEton Pharmaceuticals Announces U.S. Commercial Availability of IMPAVIDO® (miltefosine) Capsules
ETONEton Pharmaceuticals8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1 PRESS RELEASE IMPAVIDO LAUNCH
CYDYCytoDynDEF 14AProxy statement
CRVOCervoMedReleaseCervoMed Announces Pharmacokinetic Results with New Neflamapimod Oral Tablet Formulation and Secures FDA Removal of Drug Exposure Limit → BD updateSummary on the 8-K
CRVOCervoMed8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updateCervoMed just announced a new 50 mg tablet formulation, a switch to 100 mg BID dosing, and — critically — FDA removal of the prior plasma exposure limit, delivering the most complete CMC and regulatory de-risking of neflamapimod since the Bad Batch fix began.BD extracted 1 program update from this document → CRVO pipeline
ARVNArvinasS-8Employee plan registrationSummary on the release
ARVNArvinasReleaseArvinas Announces First Patient Dosed in Phase 1/2 Clinical Trial of ARV-6723, the Company’s First Immuno-Oncology CandidateARV-6723, Arvinas's first immuno-oncology PROTAC targeting HPK1, has dosed its first patient — the one 2H 2026 catalyst that actually stayed on schedule after the ARV-102 PSP hold pushed the rest of the wholly-owned pipeline into 2027.
ALDXAldeyra TherapeuticsReleaseAldeyra Therapeutics to Host Regulatory Update Webcast
ACHVAchieve Life SciencesReleaseAchieve Life Sciences to Present 52-Week Cytisinicline Efficacy Data for Smoking and E-Cigarette Cessation at CHEST 2026BD extracted 1 program update from this document → ACHV pipeline
ACETAdicet BioReleaseAdicet Bio Announces Positive Safety and Efficacy Data from Prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus with or without Lupus Nephritis → BD updateSummary on the 8-K
ACETAdicet Bio8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe 22-patient prula-cel Phase 1 readout is in: 50% complete renal response and 54% DORIS remission at 12 months, safety profile intact, FDA-aligned pivotal design confirmed — yet the stock is trading down ~31% from the September 1 close, a reaction that deserves a careful dissection of what the data actually shows versus what the market may have priced in.BD extracted 1 program update from this document → ACET pipeline

Friday, September 2527

VKTXViking Therapeutics424B5Prospectus supplement (offering)
VKTXViking Therapeutics424B5Prospectus supplement (offering)
STOKStoke Therapeutics8-KCurrent report: officer / director change
SRPTSarepta TherapeuticsReleaseSarepta Therapeutics Announces Presentations at 2026 World Muscle Society Annual Congress
SLSSELLAS Life Sciences GroupReleaseSELLAS Life Sciences Presents Preclinical Data Demonstrating SLS009 Activity in Pancreatic Cancer Models at the 2026 AACR Conference on Pancreatic Cancer
QNRXQuoin PharmaceuticalsEFFECTRegistration effective
QNRXQuoin Pharmaceuticals424B3Prospectus (resale / update)
OCGNOcugenReleaseOcugen Receives Provisional Approval and Priority Designation Under the Longevity and Regenerative Therapies Act in The Bahamas to Provide OCU400 to Patients for Treatment of Retinitis Pigmentosa
NRSNNeuroSense TherapeuticsReleaseNeuroSense Provides Business Update and Progress for the First Half of 2026 → BD updateSummary on the 6-K
NRSNNeuroSense Therapeutics6-KForeign issuer report · EX-99.1 PRESS RELEASE DATED SEPTEMBER 25, 2026 → BD updateNRSN has surged +1,633% since the 1-for-20 reverse split — with no new science and no financing disclosed — while today's H1 6-K puts $231K cash, a $1.99M six-month burn, and a newly disclosed Q3 2027 PARAGON timeline on the record.BD extracted 1 program update from this document → NRSN pipeline
NKTRNektar Therapeutics8-KCurrent report: other events → BD updateNektar won $90M from Lilly at trial — yet the stock is down 19% today. The verdict closes one tracked catalyst but the market's reaction suggests investors are reading the quiet-period data timing, not the litigation win, as the real signal.
NGENNervGen PharmaReleaseNervGen to Restate Previously Filed Financial Statements Recognizing Non-Cash Accounting Adjustmentsvia aggregator→ BD updateSummary on the 6-K
NGENNervGen Pharma6-KForeign issuer report → BD updateNervGen's Audit Committee just declared every financial statement I've cited since the original deep dive unreliable — the company is restating FY2024, FY2025, and Q2 2026 financials for non-cash accounting errors in stock option and warrant derivative valuations. The "C$86.8M funded through 1H 2028" runway figure that anchored my August verdict now carries an asterisk until the restated numbers land.
MBRXMoleculin BiotechReleaseAnnamycin Turns “Cold” Pancreatic Tumors “Hot” in New Preclinical Data Presented at AACRBD extracted 1 program update from this document → MBRX pipeline
MBRXMoleculin Biotech8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1
MAIAMAIA BiotechnologyS-3Shelf registrationMAIA quietly filed an S-3 after today's close registering 751,879 shares issued to PoC Capital LLC under an August 29 Clinical Trial Funding Agreement — trading a small equity stake for $1M in trial funding, a non-dilutive structure that signals management is bridging the tightening runway without a marketed offering.
LEGNLegend BiotechReleaseLegend Biotech Presents CARVYKTI Data Showing Half of Patients with RRMM Remained Progression-Free and Alive Five Years After a Single Infusion
LEGNLegend Biotech6-KForeign issuer report · EX-99.1 PRESS RELEASEBD extracted 1 program update from this document → LEGN pipeline
KODKodiak SciencesReleaseKodiak Sciences to Present Topline Results on September 28, 2026 from DAYBREAK Pivotal Phase 3 Study of Zenkuda and KSI-501 in Patients with Wet Age-Related Macular DegenerationDAYBREAK topline data drops Monday September 28 — the single catalyst that gates the BLA, the IL-6 platform thesis, and the inevitable financing. The stock's 19% pre-readout slide suggests the market is getting cold feet; here's what the data needs to show, and how to think about sizing into a confirmed coin flip.BD extracted 2 program updates from this document → KOD pipeline
IXHLIncannex Healthcare10-KAnnual reportBD extracted 1 program update from this document → IXHL pipeline
FATEFate TherapeuticsReleaseFate Therapeutics Announces Receipt of California Institute for Regenerative Medicine (CIRM) CLIN2 Grant to Advance RECLAIM-LNvia aggregatorFate Therapeutics secured a CIRM CLIN2 grant to advance RECLAIM-LN — non-dilutive capital that takes a small but real bite out of the financing overhang I called the single biggest structural risk in the original deep dive.
CYDYCytoDynS-3Shelf registration
CYDYCytoDynPOS AMPost-effective amendment
CYDYCytoDynPOS AMPost-effective amendment
CMMBChemomab TherapeuticsS-4Merger registration → BD updateThe S-4 that I told readers to wait for just landed — and Scipher's audited financials reveal a diagnostics business in freefall: revenue down 53% year-over-year in 2025 and another 79% in H1 2026, a $328M accumulated deficit, its own going-concern language, and a $10M lawsuit from a former partner.
CCCCC4 TherapeuticsReleaseC4 Therapeutics Presents New Biomarker Data from the Cemsidomide Phase 1 Trial with Dexamethasone and Phase 1b Trial with Elranatamab (ELREXFIO®) in Relapsed/Refractory Multiple Myeloma at the 23rd In → BD updateSummary on the 8-K
CCCCC4 Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe 75 µg cemsidomide + elranatamab safety cohort cleared — the "canary in the coal mine" just sang — but the stock is down 23% since August, suggesting the market is not pricing this as the clean combination signal the bull thesis required.BD extracted 1 program update from this document → CCCC pipeline
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
APVOAptevo TherapeuticsS-8Employee plan registration
ADAGAdagene6-KForeign issuer report
ACETAdicet BioReleaseAdicet Bio to Host Webcast to Present Prula-cel (formerly ADI-001) Clinical Data in Patients with Systemic Lupus Erythematosus with or without Lupus Nephritis

Thursday, September 2422

VSTMVerastemReleaseVerastem Oncology Announces Late-Breaking Oral Presentation of RAMP 201 Low-Grade Serous Ovarian Cancer Molecular Profiling and Tumor Biomarker Analysis at IGCS 2026 Annual Global MeetingBD extracted 1 program update from this document → VSTM pipeline
VKTXViking TherapeuticsReleaseViking Therapeutics Prices Upsized $500 Million Offering of Common Stock and Convertible Senior Notes → BD updateSummary on the FWP
VKTXViking TherapeuticsFWPFree writing prospectus (offering terms)→ BD updateThe $500M Viking raise just priced: 7.86M shares at $35.00 (a 16% discount to Tuesday's close) plus $225M of 2% convertible notes converting at $50.75. The deal was upsized from $400M — strong institutional demand — but the pricing discount drove VKTX down 11.8% today. Here's what the final terms mean for dilution, runway, and the M&A pitch.
VKTXViking Therapeutics305B2305B2 → BD updateSummary on the FWP
SRPTSarepta TherapeuticsReleaseSarepta Therapeutics to Present New Data from its Neuromuscular Portfolio at 27th Annual Neuromuscular Study Group Scientific MeetingBD extracted 3 program updates from this document → SRPT pipeline
NVCTNuvectis PharmaReleaseNuvectis Announces NXP200 Granted Breakthrough Therapy Designation in China for BRAF V600-Mutant, Recurrent or Progressive, High-Grade Gliomavia aggregatorNXP200, the paradox-breaker BRAF inhibitor I've been calling the speculative leg of the Nuvectis portfolio, just received Breakthrough Therapy Designation in China for BRAF V600-mutant high-grade glioma — weeks before the ESMO oral that will show the dataset behind it for the first time.
NGENNervGen Pharma6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
MISTMilestone PharmaceuticalsReleaseMilestone Pharmaceuticals Enrolls First Canadian Study Participant in ReVeRA-301 Phase 3 Pivotal Trial Evaluating Etripamil Nasal Spray for AFib-RVR
MESOMesoblast6-KForeign issuer report · EX-99.1
MDNAFMedicenna TherapeuticsReleaseMedicenna Announces Oral Presentation of New Bizaxofusp Results in Recurrent Glioblastoma at the 2026 Society for Neuro-Oncology Annual Meeting
LEGNLegend Biotech6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
KYTXKyverna TherapeuticsReleaseKyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person Syndrome and Generalized Myasthenia Gravis → BD updateSummary on the 8-K
KYTXKyverna Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1 → BD updateKYSA-8's one-year SPS data just deepened — T25FW improvement went from 46% at Week 16 to 49% at Month 12, with 95% of responders holding their gains and the BLA still on track for Q4. The stock is down 16% on the day despite what looks like a clean durability receipt.BD extracted 1 program update from this document → KYTX pipeline
IMRXImmuneeringReleaseImmuneering to Present at the ESMO Congress 2026
HURATuHURA Biosciences8-KCurrent report: debt / obligation
GUTSFractyl Health8-KCurrent report: shareholder vote
ELTXElicio TherapeuticsReleaseElicio Therapeutics Announces Late-Breaking Phase 2 AMPLIFY-7P Data Selected for Proffered Paper Oral Presentation at ESMO Congress 2026AMPLIFY-7P's "new pre-specified analyses" get a late-breaking Proffered Paper slot at ESMO on October 23 — the next data gate in a story the thesis has tracked since the June 15 ITT miss, with the stock now down another ~39% since August and cash runway still a ticking clock.BD extracted 1 program update from this document → ELTX pipeline
CGEMCullinan TherapeuticsReleaseCullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio → BD updateSummary on the 8-K
CGEMCullinan Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateCGEM is down 24.3% from the September 14 WCLC high — not on new bad news, but into a hard Q4 catalyst calendar that crystallizes three data drops across CLN-978, velinotamig, and CLN-049 between November and December.BD extracted 3 program updates from this document → CGEM pipeline
APVOAptevo TherapeuticsReleaseAptevo Advances Next-Generation Trispecific Candidate Toward Clinical Development
APVOAptevo Therapeutics8-KCurrent report: other events · EX-99.1BD extracted 1 program update from this document → APVO pipeline
ANNXAnnexonReleaseAnnexon to Present Patient Baseline Characteristics from Vonaprument Phase 3 ARCHER II Pivotal Trial for Geographic Atrophy at The Retina Society 59th Annual Scientific Meeting
ABSIAbsciReleaseAbsci Announces Preliminary Details for Phase 2 STORYLINE™ Trial of AI-Designed Antibody ABS-201™ for Endometriosisvia aggregatorAbsci just named and announced preliminary details for the Phase 2 STORYLINE™ trial of ABS-201 in endometriosis — the Q4 2026 catalyst I've been flagging since the original deep dive is now officially on the clock.

Wednesday, September 2343

ZYMEZymeworksReleaseZymeworks Completes Acquisition of Theravance Biopharma Conference call with Zymeworks management on September 28 at 8:30 am Eastern Time (ET) VANCOUVER, British Columbia, Sept. 23, 2026 (GLOBE NEWSWI → BD updateSummary on the 8-K
ZYMEZymeworks8-KCurrent report: material agreement, acquisition / disposition, debt / obligation · EX-99.1 → BD updateThe Theravance deal closed today, adding ~$360M of target cash and ~$60M/yr of YUPELRI profit-share to the balance sheet — and the $350M OMERS note terms are now fully in print, revealing an 8.25% fixed rate and a waterfall that directs 75% of YUPELRI Adjusted Net Profit to debt service.
WVEWave Life SciencesReleaseWave Life Sciences Initiates Phase 2a Combination Trial of WVE-007 (GalNAc-siRNA) with Tirzepatide for ObesityWave just pulled the trigger on the GLP-1 combination trial the bull thesis has been waiting for — WVE-007 plus tirzepatide is now dosing patients, converting the "incretin fixer" from a mechanism story into a clinical reality, even as the stock sits 31% below its July close.
VKTXViking TherapeuticsReleaseViking Therapeutics Announces Proposed Offerings of Common Stock and Convertible Senior Notes → BD updateSummary on the 424B5
VKTXViking Therapeutics424B5Prospectus supplement (offering)→ BD updateThe ink on yesterday's landmark maintenance data was barely dry before Viking announced a concurrent $200M stock + $200M convertible note offering — classic biotech playbook: use a positive catalyst to raise while the window is open, and today's offering reveals exactly how they're bridging the dilution gap I've been flagging since April.
VKTXViking Therapeutics424B5Prospectus supplement (offering)→ BD updateSummary on the 424B5
TVTXTravere TherapeuticsReleaseTravere Therapeutics Receives Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Directed to Certain Methods of Using FILSPARI® (sparsentan) in Focal Segmental G → BD updateThe USPTO just handed Travere a Notice of Allowance on FSGS method-of-use coverage for FILSPARI through October 2037 — the same extension that retired the IgAN patent cliff in May, now applied to the freshly minted FSGS monopoly that is the primary commercial growth engine.
SRPTSarepta Therapeutics8-KCurrent report: material agreementSarepta settled the REGENXBIO/UPenn AAVrh74 patent litigation for exactly the $39.0M it accrued in Q2 — and in doing so, secured a perpetual covenant-not-to-sue covering ELEVIDYS and all future AAVrh74 programs, closing the IP moat question I flagged in the original deep dive.
PRQRProQR TherapeuticsReleaseProQR Announces Appointment of Chris Hart as Chief Data and AI Officer and Thomas Wolf to join the Board of Directors as Strategic AI Advisor
PRQRProQR Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
PHIOPhio PharmaceuticalsReleasePhio Pharmaceuticals to Present Clinical Development Update and Upcoming Catalysts at Life Sciences Future 2026 ConferenceBD extracted 1 program update from this document → PHIO pipeline
PALIPalisade BioReleasePalisade Bio Expands Global Phase 2b ASCENTRA-UC Program with Health Canada CTA Clearancevia aggregator
ORKAOruka TherapeuticsReleaseOruka Therapeutics Announces Positive Week 28 Data for ORKA-001 from the Ongoing EVERLAST-A Trial Showing Deepening of Responses Without Additional Dosing → BD updateORKA-001's Week 28 EVERLAST-A data just validated the once-yearly maintenance thesis: PASI 100 deepened to 71.4% — up from 63.5% at Week 16 — six months after the last dose, with a clean safety profile. The stock is down ~14.5% from the August high, and that gap between the science and the tape is worth unpacking.BD extracted 1 program update from this document → ORKA pipeline
OCGNOcugen8-KCurrent report: shareholder vote → BD updateThe September 21 reserved-share vote the thesis has been waiting on since June 11 didn't clear — Ocugen adjourned to October 5 for another round of proxy solicitation, leaving the convertible's cash-only conversion mechanic, the going-concern tag, and the CEO's December 31 equity-settlement deadline all live for another two weeks.
NRIXNurix TherapeuticsSCHEDULE 13GPassive >5% holder (13G)
MPLTMapLight TherapeuticsEFFECTRegistration effective
MPLTMapLight Therapeutics424B3Prospectus (resale / update)
MGTXMeiraGTxReleaseMeiraGTx Appoints Accomplished Healthcare Portfolio Manager Alan M. Sebulsky to Board of Directors
MGTXMeiraGTx8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
MBRXMoleculin BiotechReleaseMoleculin Biotech Secures Mexican Patent Protecting Lung-Targeted Liposomal Annamycin Through 2040 → BD updateSummary on the 8-K
MBRXMoleculin Biotech8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updateThe ATM is running — not frozen — and the 37.1M Series I warrants have already ratcheted from $0.75 to $0.51, exactly the equity-destruction loop flagged in the deep dive. The stock is down 31.7% since last week's update, and now readers need to know why.
MAIAMAIA BiotechnologyReleaseMAIA Biotechnology Expands Pivotal Phase 3 THIO-104 Non-Small Cell Lung Cancer Trial into Spain and Portugal
LXEOLexeo TherapeuticsReleaseLexeo Therapeutics to Participate in the Stifel 2026 Virtual Cardiometabolic Forumcompany site may be offline after the acquisition
LGVNLongeveron8-KCurrent report: other events · EX-99.1 PRESS RELEASE OF LONGEVERON INC., DATED SEPTEMBER 16, 2026BD extracted 1 program update from this document → LGVN pipeline
KAPAKairos PharmaReleaseKairos Pharma to Present and Moderate at Discovery on Target Conference in Boston, MA
IONSIonis PharmaceuticalsReleaseIonis announces positive interim data from partner Roche’s Phase 3 IMAgINATION study in IgA nephropathy (IgAN)→ BD updateSummary on the 8-K
IONSIonis Pharmaceuticals8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updateSefaxersen's Phase 3 IMAgINATION study hit its primary endpoint — statistically significant UPCR reduction vs. placebo at 37 weeks in 459 IgAN patients — answering the thesis question I posed in the deep dive: was 2026 bad luck or a pattern? Two consecutive Phase 3 wins in one week say it's looking more like bad luck.BD extracted 1 program update from this document → IONS pipeline
IMVTImmunovantReleaseImmunovant Announces Topline Results from Proof-of-Concept Study of IMVT-1402 in Cutaneous Lupus Erythematosus → BD updateIMVT-1402's proof-of-concept in cutaneous lupus missed its primary endpoint (CLASI-A at Week 12, n=57), and Immunovant is killing the CLE program — but the safety profile held clean and the five remaining indications are unaffected. The question is whether this is a CLE-specific whiff or a signal about the "depth-of-IgG-suppression" thesis in skin disease.BD extracted 2 program updates from this document → IMVT pipeline
HELPHelus Pharma6-KForeign issuer report · EX-99.1
GOSSGossamer BioReleaseGossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial Hypertension → BD updateSummary on the 8-KBD extracted 1 program update from this document → GOSS pipeline
GOSSGossamer Bio8-KCurrent report: other events → BD updateGossamer's NDA for seralutinib landed today as forecast — but the stock is down 14.1% since the September 9 split announcement, decoding why the market is unmoved (or skeptical) on what looks like a milestone hit is the editorial angle.
EVMNEvommuneReleaseEvommune Announces Late-Breaker Presentation of Phase 2a Data for EVO301 in Atopic Dermatitis at European Academy of Dermatology & Venereology 2026 Congress
EVMNEvommune8-KCurrent report: Reg FD disclosure · EX-99.1
ENTXEntera BioPRE 14APRE 14A
CRDLCardiol TherapeuticsSCHEDULE 13G/A13G amendment → BD updateSummary on the 6-K
CRDLCardiol TherapeuticsReleaseCardiol Therapeutics Achieves Phase III MAVERIC Enrollment Target Ahead of Schedule and Expands Pivotal Trial to Strengthen Assessment of CardiolRx™’s Efficacy → BD updateSummary on the 6-K
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 NEWS RELEASE DATED SEPTEMBER 23, 2026 → BD updateMAVERIC hit n=110 enrollment ahead of schedule — but a blinded event review showing fewer-than-expected recurrences is forcing the Steering Committee to expand to n=150, pushing topline to mid-2027 and quietly reshuffling the primary endpoint. The market is calling it a ~6.8% haircut; the science reading is more complicated than that.
CHRSCoherus OncologyReleaseCoherus Oncology Retains Oppenheimer & Co. to Market Legacy BioSimilar Assets
CATXPerspective TherapeuticsSCHEDULE 13D/A13D amendment → BD updateLantheus's trickle has turned into a flood: Amendment No. 3 reveals three block-scale sales totaling ~2.7M shares since September 4, cutting the stake from 10.0% to 7.7% in under three weeks — the "tell" I said to watch for just landed.
BMEABiomea FusionReleaseBiomea Fusion Announces Termination of Proposed Public Offering of Securities → BD updateThe offering Biomea announced yesterday was pulled this morning — management couldn't get terms it liked, no cash was raised, and the going-concern clock is now ticking louder than ever with both Phase IIb readouts at or past the cash horizon.
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ARTVArtiva BiotherapeuticsReleaseArtiva Biotherapeutics Announces Oral Presentation of AlloNK® Clinical Data at the 17th International Symposium on Sjögren’s DiseaseBD extracted 1 program update from this document → ARTV pipeline
APVOAptevo Therapeutics8-KCurrent report: shareholder vote
AMLXAmylyx PharmaceuticalsReleaseAmylyx Pharmaceuticals to Present at the Stifel 2026 Virtual Cardiometabolic Forum
ALTAltimmuneReleaseAltimmune to Participate in Stifel Cardiometabolic Forum
ACIUAC ImmuneReleaseAC Immune Reports Positive Safety & Immunogenicity at week-100 in Part 1 of VacSYn Phase 2 Trial of ACI-7104 → BD updateSummary on the 6-K
ACIUAC Immune6-KForeign issuer report · EX-99.1 → BD updateThe VacSYn week-100 final Part 1 readout landed today — all primary endpoints met, 100% immunogenicity, confirmed CSF antibody penetration in every patient, and a target-engagement signal for CSF α-syn — the catalyst that was carrying the entire equity thesis has cleared its bar, and the FDA conversation on the registrational path is now scheduled for early 2027.BD extracted 1 program update from this document → ACIU pipeline

Tuesday, September 2243

ZBIOZenas BioPharmaReleaseZenas BioPharma Announces Upcoming Presentations of Obexelimab Data in IgG4-Related Disease at the IgG4ward! 6th International Symposium on IgG4-Related Disease and ACR Convergence 2026BD extracted 1 program update from this document → ZBIO pipeline
WVEWave Life SciencesReleaseWave Life Sciences Announces Appointment of Dr. Monika Vnuk as Chief Business OfficerWave just hired its first dedicated Chief Business Officer — a signal that the commercial and partnership infrastructure is being built out in real time, right as the FDA accelerated-approval meeting for WVE-006 lands and Phase 2a obesity dosing is underway.
VKTXViking TherapeuticsReleaseViking Therapeutics Announces Positive Topline Results from Maintenance Study of GLP-1/GIP Agonist VK2735 Demonstrating the Promise of Multiple Maintenance Dosing Regimens → BD updateSummary on the 8-K
VKTXViking Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateToday's VK2735 maintenance data delivered exactly what I've been waiting on since January: monthly dosing holds 85–90% of weight loss, every-other-week dosing holds up to 97%, and GI adverse events during maintenance were indistinguishable from placebo — the convenience moat and the tolerability bear case both resolved in a single readout.BD extracted 1 program update from this document → VKTX pipeline
SMMTSummit TherapeuticsReleaseHARMONi-GI1, a Phase III Trial Featuring Ivonescimab Plus Chemotherapy Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer from China, to BeHARMONi-GI1's full dataset — ivonescimab's first non-lung Phase III OS win over a checkpoint inhibitor — gets the ESMO 2026 Presidential Symposium slot on October 25, putting hazard ratios and medians on the table 20 days before the November 14 PDUFA.BD extracted 1 program update from this document → SMMT pipeline
SCYXScynexisReleaseSCYNEXIS Appoints Seasoned Industry Veteran Steven K. Burke, M.D., to its Board of Directors
SCYXScynexis8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1BD extracted 2 program updates from this document → SCYX pipeline
SABSSAB BiotherapeuticsReleaseSAB BIO to Present SAB-142 Data at the 62nd Annual Meeting of the European Association for the Study of DiabetesBD extracted 1 program update from this document → SABS pipeline
RYTMRhythm PharmaceuticalsReleaseRhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic ObesityHealth Canada has approved IMCIVREE for acquired hypothalamic obesity — the fourth major regulator to bless the same pivotal dataset, completing the global regulatory sweep. The stock's 11% slide from the Japan high tells the real story: the market has moved on from regulatory wins and is waiting for Q3 revenue to confirm the commercial thesis.
RVPHReviva PharmaceuticalsReleaseReviva to Participate in the Lytham Partners Fall 2026 Investor Conference
RCUSArcus BiosciencesReleaseArcus Biosciences to Host Investor Event Featuring New Data for Casdatifan as a ...BD extracted 1 program update from this document → RCUS pipeline
QNRXQuoin PharmaceuticalsReleaseQuoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome
QNRXQuoin PharmaceuticalsPRE 14APRE 14A
QNRXQuoin Pharmaceuticals8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1
PALIPalisade BioReleasePalisade Bio Receives FDA Clearance of IND for PALI-2108 in Crohn’s Disease, Expanding Phase 2 Development Across IBDvia aggregator→ BD updatePalisade Bio just cleared the FDA IND for ASCENTRA-CD — the Crohn's disease Phase 2 I flagged in the deep dive — locking in a Q1 2027 first patient and Q1 2028 readout, with a trial design that answers some questions and raises others about the single-arm, open-label structure the original writeup warned about.
NAMSNewAmsterdam PharmaSCHEDULE 13D/A13D amendment
MRKRMarker TherapeuticsReleaseMARKER THERAPEUTICS HIGHLIGHTS EXPANDED MANUFACTURING SUPPORT OF CDMO PARTNER FOLLOWING FORMATION OF KINCELLIS ADVANCED THERAPIES
MAIAMAIA BiotechnologyReleaseMAIA Biotechnology Reports Pivotal Phase 3 Clinical Trial Progress in Advanced Non-Small Cell Lung CancerBD extracted 1 program update from this document → MAIA pipeline
LXEOLexeo TherapeuticsReleaseLexeo Therapeutics Enters Into Agreement to Acquire Mantle Therapeutics and Announces Multiple New Strategic Collaborations to Expand Leadership in Friedreich Ataxia → BD updateSummary on the 8-Kcompany site may be offline after the acquisition; linked to the SEC copy · original
LXEOLexeo Therapeutics8-KCurrent report: material agreement, other events · EX-99.1 → BD updateLexeo just transformed from a focused cardiac gene therapy company into a multimodal Friedreich ataxia platform — acquiring four frataxin programs (including one in the clinic) for just $8.3M upfront, while launching three CNS gene therapy collaborations, all without touching the 2028 cash runway guidance.BD extracted 5 program updates from this document → LXEO pipeline
KZIAKazia TherapeuticsReleaseKazia Therapeutics Announces Sovargen Co. Doses First Patient in Phase 1b/2a Trial of Paxalisib for Rare Seizure Disorders
KZIAKazia Therapeutics6-KForeign issuer report · EX-99.1 PRESS RELEASE DATED SEPTEMBER 22, 2026
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
IONSIonis PharmaceuticalsReleaseIonis announces positive topline results from Phase 3 FUSION study of ulefnersen marking significant milestone in advancing first potential disease modifying treatment for FUS-ALS → BD updateAfter three straight Phase 3 failures, ulefnersen just hit its primary endpoint in FUS-ALS — a small trial but a real signal that Ionis's platform can still translate target knockdown into patient benefit. Here's what it means for the thesis.BD extracted 1 program update from this document → IONS pipeline
INABIN8bioReleaseIN8bio to Present at Sidoti Small-Cap Virtual Conference
HELPHelus PharmaReleaseHelus Pharma Announces Results of Annual and Special Meeting of Shareholders and Effective Date for Legal Name Change
HELPHelus Pharma6-KForeign issuer report · EX-99.1
ELDNEledon PharmaceuticalsReleaseEledon Presents Updated Long-Term Phase 2 BESTOW Extension Study Results at the International Congress of The Transplantation Society → BD updateEledon just received FDA Fast Track Designation for tegoprubart and presented BESTOW extension data showing the eGFR advantage vs. tacrolimus growing to ~13 mL/min/1.73m² at month 24 with statistical significance — and zero rejections in the tegoprubart arm beyond month six. The three-point delta that underwhelmed at month 12 appears to be compounding, not fading.BD extracted 1 program update from this document → ELDN pipeline
CRVOCervoMedReleaseCervoMed to Participate in the 5th Annual ROTH Healthcare Opportunities Conference
CMPXCompass TherapeuticsReleaseCompass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback → BD updateSummary on the 8-K
CMPXCompass Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1 PRESS RELEASE → BD updateThe FDA told Compass it needs a new survival trial before filing a BLA for tovecimig — the exact bear-case outcome the prior writeup named as a PASS trigger. The stock is down ~48% and the thesis, as written, is broken.BD extracted 1 program update from this document → CMPX pipeline
CLNNCleneReleaseClene to Present at Upcoming Investor Conferencesvia aggregator
CLDXCelldex TherapeuticsReleaseCelldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints → BD updateSummary on the 8-K
CLDXCelldex Therapeutics8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1 → BD updateThe coin landed heads — barzolvolimab's massive 1,939-patient Phase 3 EMBARQ program delivered a clean, best-in-disease win in CSU, but the stock is trading ~19% below the August high, creating the most interesting setup in this thesis's history.
CGENCompugenReleaseCompugen to Host Virtual KOL Event on COM701 in Ovarian Cancer & Unigen™ Platform Update on October 5, 2026
BMEABiomea FusionReleaseBiomea Fusion Announces Proposed Public Offering of Securities → BD updateSummary on the 8-K
BMEABiomea Fusion8-KCurrent report: other events → BD updateThe dilution event the thesis predicted since the deep dive is officially here — Biomea has launched an underwritten public offering today, and the 8-K simultaneously revealed BMF-650 weight data is now expected in October 2026, not "Q3," meaning the financing catalyst and the data catalyst are now landing in the same window.
BMEABiomea Fusion424B5Prospectus supplement (offering)→ BD updateSummary on the 8-K
AUTLAutolus TherapeuticsEFFECTRegistration effective
AUTLAutolus Therapeutics424B3Prospectus (resale / update)
ADAGAdageneReleaseAdagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager
ADAGAdagene6-KForeign issuer report · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → ADAG pipeline

Monday, September 2124

XFORX4 PharmaceuticalsSCHEDULE 13GPassive >5% holder (13G)
XENEXenon PharmaceuticalsReleaseXenon to Present at TD Cowen Novel Mechanisms in Neuropsychiatry & Epilepsy Summit
TYRATyra BiosciencesSCHEDULE 13GPassive >5% holder (13G)
TVTXTravere TherapeuticsReleaseTravere Therapeutics Announces Planned Chief Executive Officer Transition → BD updateSummary on the 8-K
TVTXTravere Therapeutics8-KCurrent report: officer / director change → BD updateEric Dube is stepping down as CEO for health reasons effective December 1, replaced by Bradley Campbell — former Amicus Therapeutics CEO who scaled Galafold into a global rare disease franchise. The succession choice tells a story about where Travere is headed: this is a pure commercial execution hire, not a science or pipeline hire, arriving at exactly the right moment in FILSPARI's trajectory.
TLXTelix Pharmaceuticals6-KForeign issuer report · EX-99.1
TLSATiziana Life Sciences6-KForeign issuer report · EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 21, 2026
SIONSionna TherapeuticsSCHEDULE 13D/A13D amendment
RXRXRecursion Pharmaceuticals8-KCurrent report: material agreement
QTTBQ32 BioReleaseQ32 Bio Announces Upcoming Late-Breaking Presentation of Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata at the European Academy of Dermatology and Venereology CoBD extracted 1 program update from this document → QTTB pipeline
PALIPalisade BioReleasePalisade Bio to Present at Stifel 2026 Virtual Immunology and Inflammation Forum
NAMSNewAmsterdam PharmaReleaseNewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)→ BD updateSummary on the 8-K
NAMSNewAmsterdam Pharma8-KCurrent report: other events → BD updateEurope just said yes — the EC granted full marketing authorization for Ubeslo® and Evlarco® today, the first regulatory approval of obicetrapib anywhere in the world, triggering milestone payments and opening the royalty clock. The stock is down ~18% since August. Here's why the market isn't celebrating, and what the EC's PREVAIL condition actually means for the thesis.
INSMInsmedReleaseFDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027 → BD updateThe FDA granted Priority Review to Insmed's ARIKAYCE sNDA and set a PDUFA date of January 28, 2027 — pulling the potential full-approval decision ~5–6 months earlier than the mid-2027 standard-review timeline I modeled, and converting a vague catalyst into a hard binary event date.
HRMYHarmony BiosciencesReleaseHarmony Biosciences Recognizes World Narcolepsy Day 2026, Reflecting on Nearly a Decade of Commitment to the Sleep Community
HELPHelus PharmaReleaseHelus Pharma Presents New Analyses on HLP003 in Major Depressive Disorder at Psych Congress 2026BD extracted 1 program update from this document → HELP pipeline
HELPHelus PharmaReleaseHelus Pharma to Participate at the TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit
HELPHelus Pharma6-KForeign issuer report · EX-99.1
CUECue Biopharma8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe binary the thesis was built on just fired: CUE-221's Phase 2 CSU data landed positive, with primary and key secondary endpoints met and a durability signal 12 weeks off-drug that omalizumab couldn't match — the first clinical evidence that the CD23 dual-MOA is real beyond a petri dish.BD extracted 1 program update from this document → CUE pipeline
CLNNCleneReleaseClene Announces Closing of $4 Million Registered Direct Offering Extending Capital Runway Beyond FDA Decision on CNM-Au8® NDA
CGEMCullinan TherapeuticsReleaseCullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum
ATAIAtai Beckley15-12G15-12G
ANIXAnixa BiosciencesReleaseSEP 21, 2026 8:45 AM EDT Anixa Biosciences Granted First Australian Patent for its Breast Cancer Vaccine, Broadening Global Protection Through 2040↗ IP Australia has issued Patent Number 2020221280 re
ANABAnaptysBioReleaseAnaptys Announces Second Quarter and Transitional Fiscal Year 2026 Financial Results and Provides Business Update → BD updateSummary on the 8-K
ANABAnaptysBio8-KCurrent report · EX-99.1 → BD updateAZUR-1 hit: Jemperli achieved a sustained clinical complete response at 12 months in dMMR rectal cancer, the label expansion that underwrites GSK's >$2.7B peak-sales thesis — with a February 2027 PDUFA and ESMO data presentation in five weeks. The royalty machine's first audited annual report is also in, and the Sagard paydown clock just slipped to H2 2027.BD extracted 1 program update from this document → ANAB pipeline
ANABAnaptysBio10-KT10-KT → BD updateSummary on the 8-K
ACRSAclaris TherapeuticsSCHEDULE 13GPassive >5% holder (13G)
ABVXAbivaxF-6EFF-6EF
ABVXAbivax6-KForeign issuer report · EX-99.1

Sunday, September 201

CUECue BiopharmaReleaseCue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous Urticaria → BD updateSummary on the 8-K of Sep 21, 2026

Friday, September 1811

QNRXQuoin PharmaceuticalsS-3Shelf registration
OTLKOutlook Therapeutics8-KCurrent report: other events → BD updateOTLK set LYTENAVA's U.S. WAC at $485/vial on September 16 — landing in the middle of the $400–600 range from the original bull case, but WAC is the ceiling, not the floor, and the $50 Avastin conversion problem is unchanged.
MPLTMapLight TherapeuticsS-1/ARegistration statement (amended)
MBRXMoleculin Biotech8-KCurrent report: listing notice → BD updateThe Nasdaq delisting determination I flagged in mid-September has arrived exactly on schedule — and the stock is up +26.5% anyway. Here's what the 8-K actually means for the thesis.
KZIAKazia Therapeutics6-KForeign issuer report
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
GRCEGrace Therapeutics8-KCurrent report: shareholder vote
ELOXEloxx PharmaceuticalsEFFECTRegistration effective
CBIOCrescent BiopharmaS-8Employee plan registration
ATHEAlterity TherapeuticsS-8Employee plan registration
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1

Thursday, September 1712

XENEXenon PharmaceuticalsReleaseXenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical Program → BD updateThe azetukalner NDA is officially in — the epilepsy fortress keeps its walls — but a voluntary enrollment pause in the psychiatry studies due to unexpected neuropsychiatric AEs just made the "free call option" thesis look more complicated than free.BD extracted 1 program update from this document → XENE pipeline
TYRATyra BiosciencesSCHEDULE 13GPassive >5% holder (13G)→ BD updateSummary on the SCHEDULE 13D/A
TYRATyra BiosciencesSCHEDULE 13D/A13D amendment → BD updateRA Capital spent $200M of the September $400M offering on pre-funded warrants — hitting the 19.99% cap — and a new specialist holder, Paradigm BioCapital (5.8%), emerged from the same deal, deepening the smart-money register at a price 23% below the August ATM authorization.
TVTXTravere TherapeuticsReleaseTravere Therapeutics to Present at the Stifel 2026 Virtual Immunology and Inflammation Forum
TLSATiziana Life Sciences6-KForeign issuer report · EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 17, 2026
RAREUltragenyx PharmaceuticalReleaseUltragenyx Announces Approval of FAYUVI™ Gene Therapy, the First-Ever FDA-Approved Treatment for Sanfilippo Syndrome Type A (MPS IIIA)→ BD updateSummary on the 8-K
RAREUltragenyx Pharmaceutical8-KCurrent report: other events → BD updateFAYUVI (UX111) just received standard full FDA approval for Sanfilippo syndrome Type A — a historic first-in-disease milestone that lands 15 days after the crown jewel Angelman failure cratered the stock 45%, and the disconnect between the approval quality and the price tells a story worth unpacking.
KPRXKiora PharmaceuticalsSCHEDULE 13GPassive >5% holder (13G)
HURATuHURA Biosciences8-K/ACurrent report (amended): officer / director change
HURATuHURA Biosciences8-KCurrent report: debt / obligation
GANXGain TherapeuticsReleaseGain Therapeutics to Participate at ROTH Fifth Annual Healthcare Opportunities Conference
CINGCingulateReleaseShane Schaffer, Cingulate Chairman & CEO to Present “SMART Launch” Approach at Indegene Digital Summit: Rethinking Commercialization for Emerging Pharma
CAPRCapricor TherapeuticsReleaseCapricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society CongressBD extracted 1 program update from this document → CAPR pipeline
ATAIAtai BeckleyS-8 POSEmployee plan registration (post-effective)
ARTVArtiva BiotherapeuticsReleaseArtiva Biotherapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum

Wednesday, September 1620

REPLReplimune Group8-KCurrent report: charter / bylaws / fiscal year, shareholder vote
NRXPNRX Pharmaceuticals8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1
MAIAMAIA BiotechnologyReleaseMAIA Biotechnology Doses First U.S. Patient in Ongoing Phase 2 Non-Small Cell Lung Cancer Clinical TrialThe first U.S. patient has been dosed in THIO-101 Parts C/D — the cohort anchoring MAIA's Accelerated Approval pathway — funded by a $2.3M NIH grant, closing a key operational gap I've been tracking since the Phase 3 interim slipped to 2027.
LGVNLongeveronReleaseLongeveron Announces Topline Results from ELPIS II Phase 2b Clinical Trial Evaluating Laromestrocel as a Potential Treatment for Hypoplastic Left Heart Syndrome (HLHS)→ BD updateELPIS II missed its primary endpoint (RVEF p=0.8336), the company is exploring "all options to maximize shareholder value," and the binary event the thesis was built around has resolved — negatively. The lottery ticket didn't hit, and the escape hatches are now closed behind them.BD extracted 1 program update from this document → LGVN pipeline
KTTAPasithea Therapeutics8-KCurrent report: other events
KTTAPasithea Therapeutics25-NSEDelisting notice
KROSKeros TherapeuticsEFFECTRegistration effective
INSMInsmedReleaseInsmed Expands Community Impact During Fifth Annual Global Day of Good
HURATuHURA Biosciences8-KCurrent report: officer / director change
GOSSGossamer BioReleaseGossamer Bio Appoints Greg Ciongoli to Board of Directors
GOSSGossamer BioDEF 14AProxy statement
GOSSGossamer Bio8-KCurrent report: officer / director change · EX-99.1
CRDLCardiol TherapeuticsSUPPLSUPPL → BD updateSummary on the 6-K
CRDLCardiol TherapeuticsReleaseCardiol Therapeutics Announces Warrant Exercise for Over USD $7 Million in Proceeds → BD updateSummary on the 6-K
CRDLCardiol TherapeuticsF-10/AF-10/A → BD updateSummary on the 6-K
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 NEWS RELEASE DATED SEPTEMBER 16, 2026 → BD updateCardiol just received >USD $7 million from the warrant exercises it triggered via acceleration notice, pushing cash runway to H1 2028 — directly addressing the dilution concern I flagged in last week's post — without a single share sold below market.
CMPSCOMPASS PathwaysReleaseCompass Pathways to Participate in TD Cowen 6th Annual Novel Mechanisms in Neuropsychiatry Summit on September 23, 2026
CLNNClene8-KCurrent report: material agreement, other events · EX-99.1 EXHIBIT 99.1
CLNNClene424B5Prospectus supplement (offering)
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ATAIAtai BeckleyS-8 POSEmployee plan registration (post-effective)
ATAIAtai BeckleyS-8 POSEmployee plan registration (post-effective)
ANIXAnixa BiosciencesReleaseAnixa Biosciences Appoints UPenn's Dr. Carmen Guerra to Cancer Business Advisory Board
ANIXAnixa BiosciencesReleaseSEP 16, 2026 9:30 AM EDT Anixa Biosciences Appoints UPenn's Dr. Carmen Guerra to Cancer Business Advisory Board↗ The appointment of Carmen Guerra, M.D., M.S.C.E., F.A.C.P., to its Cancer Business Advi
ABOSAcumen Pharmaceuticals8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 1 program update from this document → ABOS pipeline

Tuesday, September 1525

VERAVera TherapeuticsReleaseVera Therapeutics Announces TRUTAKNA™ (atacicept-vymj) Stabilized eGFR and Prevented Kidney Disease Progression Through Two Years in ORIGIN 3 Final Efficacy Analysis in IgA Nephropathy → BD updateSummary on the 8-K
VERAVera Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateORIGIN 3's final eGFR analysis just delivered the data I've been tracking all year: TRUTAKNA stabilized kidney function through two years with a 76% risk reduction in composite kidney progression — the confirmatory win that converts a conditional accelerated label into a full-approval story, and clears the last major scientific binary for the Lazarus drug thesis.BD extracted 1 program update from this document → VERA pipeline
TYRATyra Biosciences8-KCurrent report: other events · EX-99.1
TYRATyra Biosciences424B5Prospectus supplement (offering)
SMMTSummit TherapeuticsReleaseUpdated HARMONi Data Presented at WCLC 2026 Demonstrate Consistent Overall Survival Results with Ivonescimab Plus Chemotherapy in Western and Asian Patients → BD updateSummary on the 8-K
SMMTSummit Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateThe WCLC data Summit's FDA reviewers have been waiting for just landed: HARMONi's Western OS hazard ratio has converged to 0.76 at 23.2 months of follow-up, matching the global ITT exactly — and the full HARMONi-2 numbers vs. Keytruda arrived with them. The stock is selling off anyway, and that disconnect deserves a close read.BD extracted 1 program update from this document → SMMT pipeline
SCYXScynexisReleaseSCYNEXIS Appoints Todd Minga, M.D., as Senior Vice President, Research & Developmentvia aggregatorA career nephrologist with Akebia/Maze Therapeutics pedigree just took the R&D helm at SCYX — the third piece of the credibility gap closing since the deep dive, and the most operationally significant for an ADPKD-pivoting company with no kidney-disease data yet.
SCYXScynexisReleaseSCYNEXIS Appoints Todd Minga, M.D., as Senior Vice President, Research & DevelopmentSummary on the release
RCKTRocket PharmaceuticalsReleaseRocket Pharmaceuticals Announces FDA Alignment on Path to Complete Pivotal Phase 2 Trial of RP-A501 in Danon Disease → BD updateSummary on the 8-K
RCKTRocket Pharmaceuticals8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1 → BD updateThe FDA just handed Rocket a clear, locked regulatory runway for the Danon pivotal: 12 patients, co-primary endpoints preserved, and continued enrollment green-lit — the exact alignment the August 10 update said was the "tell worth watching."BD extracted 1 program update from this document → RCKT pipeline
PYPDPolyPidReleasePolyPid Announces Participation in Upcoming Fall Investor Conferences
PMVPPMV PharmaceuticalsSCHEDULE 13GPassive >5% holder (13G)
NRXPNRX PharmaceuticalsReleaseNRx Pharmaceuticals (Nasdaq: NRXP) Reports Update from the FDA Revising Previous Major Amendment to a Minor Amendment for Preservative-free Ketamine → BD update
MAIAMAIA BiotechnologyReleaseMAIA Biotechnology Announces Open Market Purchases of Company Stock by Long-Standing Board Member and CEOA board member and the CEO stepped back into the open market — $352K combined, D&O ownership now at 21.34% — signaling insider conviction ahead of the Part C ORR readout and the tightening runway flagged last month.
LEGNLegend BiotechReleaseLegend Biotech Appoints Ingrid Zhang as Chief Executive Officer → BD updateSummary on the 6-K
LEGNLegend Biotech6-KForeign issuer report · EX-99.1 PRESS RELEASE → BD updateLegend has filled its CEO vacancy — Ingrid Zhang, former CCO of Novartis International, takes the helm today, resolving the leadership overhang flagged in both the deep dive and the August 11 update, while the stock sits 19% below that update's close ahead of the December 23 anito-cel PDUFA.
LBRXLB Pharmaceuticals8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
LBRXLB Pharmaceuticals424B3Prospectus (resale / update)
EVMNEvommune8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 2 program updates from this document → EVMN pipeline
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
COYACoya Therapeutics8-KCurrent report: other events
COGTCogent BiosciencesReleaseCogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)→ BD updateThe FDA accepted Cogent's AdvSM NDA and set a June 29, 2027 PDUFA — completing the regulatory triple-play across all three bezuclastinib indications, with no AdCom and no review issues flagged for the third time in a row.BD extracted 1 program update from this document → COGT pipeline
CNTBConnect BiopharmaReleaseConnect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adult and Adolescent Participants with Ast → BD updateSummary on the 8-K
CNTBConnect Biopharma8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe Seabreeze STAT Asthma coin has landed — and it landed on its edge. Rademikibart's Day 7 FEV₁ signal hit (Δ130 mL, p=0.023), but the primary treatment-failure endpoint missed statistical significance (p=0.153), and the stock has cratered ~50% on data that the company is calling "positive."BD extracted 1 program update from this document → CNTB pipeline
CMPSCOMPASS PathwaysReleaseCompass Pathways Launches ‘Change the Tune in TRD’ in the U.S. to Advance HCP Understanding of Treatment-Resistant Depression at Psych Congress 2026
CLNNCleneReleaseClene Announces $4 Million Registered Direct Offering → BD updateClene's Chairman, CEO, and founding investor just led a $4M raise at $3.28 — the lowest price yet — buying the company to mid-Q1 2027 while the NDA filing window opens. Insider participation is a real signal; the price and size are a real warning.
AUTLAutolus TherapeuticsDEL AMDEL AM

Monday, September 1438

TYRATyra BiosciencesS-3ASRAutomatic shelf registration → BD updateFive days after the SURF302 miss sent the stock -32%, Tyra priced a $400M underwritten offering — the largest capital raise in its history — locking in runway well past every remaining catalyst but crystallizing the dilution faucet I warned about in both prior updates.
TYRATyra BiosciencesReleaseTyra Announces Pricing of $400 Million Underwritten Offering of Common Stock and Pre-Funded Warrants → BD updateSummary on the S-3ASR
TYRATyra BiosciencesFWPFree writing prospectus (offering terms)→ BD updateSummary on the S-3ASR
TLXTelix Pharmaceuticals6-KForeign issuer report · EX-99.1
SMMTSummit Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateThe HARMONi-2 OS numbers have landed at WCLC 2026: HR 0.73 (95% CI 0.57–0.95; p=0.009), median OS 30.8 vs. 22.6 months — a 27% reduction in the risk of death vs. pembrolizumab, with the PD-L1-high subgroup posting an HR of 0.58 that speaks directly to HARMONi-7's design.BD extracted 1 program update from this document → SMMT pipeline
SIONSionna TherapeuticsReleaseSionna Therapeutics Announces Plans to Advance SION-451 + SION-2222 Dual Combination into Phase 2a Proof-of-Concept Trial → BD update
SIONSionna Therapeutics8-KCurrent report: exit / restructuring costs, officer / director change, other events · EX-99.1 → BD updateBD extracted 1 program update from this document → SION pipeline
RVMDRevolution MedicinesReleaseRevolution Medicines Announces U.S. FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) in Combination with Chemotherapy for First Line Metastatic Pancreatic Cancer → BD updateThe FDA just handed RASONQUE its third Breakthrough Therapy Designation — this one for 1L PDAC in combination with GnP, the exact setting that drives the $5B consensus — tightening the regulatory runway for RASolute 303 while the stock quietly bleeds 4.8% off its approval-day close.BD extracted 1 program update from this document → RVMD pipeline
QTTBQ32 Bio8-KCurrent report: Reg FD disclosure, other events · EX-99.1
PHIOPhio PharmaceuticalsReleasePhio Announces Key Development Milestone for PH-762 with FDA Submission Supporting Next Stage of Clinical Development in Cutaneous Squamous Cell Carcinoma → BD update
PHIOPhio Pharmaceuticals8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1 → BD updateBD extracted 1 program update from this document → PHIO pipeline
NRXPNRX PharmaceuticalsReleaseGeNeuro, Inc., an NRx Company (Nasdaq:NRXP) is awarded European Patent Rights for GNK-301, a novel drug candidate to treat Amyotrophic Lateral Sclerosis (ALS)BD extracted 1 program update from this document → NRXP pipeline
NRXPNRX Pharmaceuticals8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1
MBRXMoleculin BiotechReleaseMoleculin to Showcase New Annamycin Data at AACR Conference on Pancreatic Cancer and Two European Scientific Meetings
MBRXMoleculin Biotech8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → MBRX pipeline
LGVNLongeveron8-KCurrent report: other events
LEGNLegend Biotech6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
KTTAPasithea TherapeuticsReleasePasithea Therapeutics Announces Presentation of Initial PAS-004 Clinical Data from Ongoing Phase 1/1b Clinical Trial in Adult NF1 Patients at the 2026 European Neurofibromatosis ConferenceThe NF1 "marquee event" just got a date and an address: PAS-004's first clinical data from the NF1 Phase 1/1b trial drops November 12–13 in Vienna, with CN data earning an oral slot and PN data in a poster — the catalyst geometry just got a lot sharper.BD extracted 1 program update from this document → KTTA pipeline
KAPAKairos Pharma8-KCurrent report: Reg FD disclosure · EX-99.1
JANXJanux TherapeuticsReleaseJanux Therapeutics Announces First Patient Dosed in Phase 1 Study of JANX013 → BD updateJANX013 — the CD28 co-stimulatory "Signal 2" franchise protector I've been tracking — just dosed its first patient, on schedule, in combination with JANX007. The clinical org is executing through the CMO vacancy; the PSMA moat is widening.BD extracted 1 program update from this document → JANX pipeline
INMBInmune BioReleaseINmune Bio Appoints Sanofi Rare-Disease Executive and Biopharma Business Development Leader to Board
INMBInmune Bio8-KCurrent report: officer / director change, other events · EX-99.1 PRESS RELEASE DATED SEPTEMBER 14, 2026
IMCRImmunocore8-KCurrent report: Reg FD disclosure · EX-99.1
ELTXElicio Therapeutics8-KCurrent report: shareholder nominations, other events
DFTXDefinium TherapeuticsReleaseDefinium Therapeutics Announces Positive Topline Results from Phase 3 Panorama Study of DT120 ODT in Generalized Anxiety Disorder → BD updateSummary on the 8-K
DFTXDefinium Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updatePanorama hit — the GAD active-control study that I called the "single most important design choice in the entire Phase 3 program" delivered a positive readout today (d=0.64, p<0.0001), directly answering the functional unblinding objection while opening the NDA runway. Three-for-three on pivotals; the last domino has fallen.BD extracted 1 program update from this document → DFTX pipeline
CTNMContineum Therapeutics8-KCurrent report: other events · EX-99.1
CGEMCullinan TherapeuticsReleaseCullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer → BD updateSummary on the 8-K
CGEMCullinan Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe REZILIENT3 numbers are finally in the open — a 6-month median PFS gain (14.5 vs. 8.5 months, HR 0.50, p=0.00015) and a 65% response rate in first-line EGFR exon 20 insertion NSCLC, presented in a Presidential Symposium at WCLC 2026, turning the ATM Machine thesis from a topline assumption into a quantified, conference-validated data set.BD extracted 1 program update from this document → CGEM pipeline
CATXPerspective TherapeuticsReleasePerspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda® (Pembrolizumab) in FAP-α Positive Solid Tumors → BD updateSummary on the 8-K
CATXPerspective Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateMerck just handed CATX a no-cost supply of Keytruda to combine with PSV359 in FAP-α-positive NSCLC and colorectal cancer — a third-party scientific endorsement of the pan-cancer alpha thesis and a meaningful offset to the Lantheus overhang that cracked the M&A leg of the story ten days ago.
CAPRCapricor TherapeuticsSCHEDULE 13GPassive >5% holder (13G)Millennium Management (Izzy Englander's $70B+ multi-strat) just crossed 5.1% of CAPR with a September 8 event date — the third specialist institution to cross the 5% threshold, bringing disclosed specialist ownership to ~17% of the float with 10 weeks left to the November 22 PDUFA.
CABACabaletta Bio8-KCurrent report: other events → BD updateThe $2.50 warrant wall I flagged in August as the loudest near-term technical overhang just resolved in the best possible way: ~46M warrants exercised at expiry, ~$128M in total proceeds coming in, and the mechanical lid on CABA is gone.
BCTXBriaCell TherapeuticsReleaseData Safety Monitoring Board (DSMB) Recommends Continuing BriaCell’s Phase 3 Metastatic Breast Cancer Studyvia aggregatorBD extracted 1 program update from this document → BCTX pipeline
AUTLAutolus TherapeuticsS-3Shelf registration
ATAIAtai BeckleySCHEDULE 13D/A13D amendment
APGEApogee Therapeutics15-12G15-12G
ANTXAN2 TherapeuticsS-8Employee plan registration
AKBAAkebia TherapeuticsReleaseAkebia Therapeutics Announces First Patient Dosed in Phase 2 Basket Trial of Ebribafusp in Rare Complement-Mediated Kidney DiseasesBD extracted 1 program update from this document → AKBA pipeline
AGMBAgomab TherapeuticsReleaseAgomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis and Design of Phase 2 INSPIRIA Study → BD updateSummary on the 6-K
AGMBAgomab Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1 → BD updateAGMB-447's Phase 1b in n=10 IPF patients just confirmed lung-restricted PK and >50% pSMAD3 knockdown in fibrotic lungs — proof-of-mechanism in actual patients, not healthy volunteers — and the INSPIRIA Phase 2 (n=120, FVC primary, CTA submitted) is ready to launch before year-end.BD extracted 2 program updates from this document → AGMB pipeline

Sunday, September 133

SMMTSummit TherapeuticsReleaseIvonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso’s HARMONi-2 Study Condu → BD updateSummary on the 8-K of Sep 14, 2026BD extracted 1 program update from this document → SMMT pipeline
DFTXDefinium TherapeuticsReleaseDefinium Therapeutics to Discuss Topline Results from Phase 3 Panorama Study in Generalized Anxiety Disorder on September 14, 2026 → BD updateSummary on the 8-K of Sep 14, 2026BD extracted 1 program update from this document → DFTX pipeline
CGEMCullinan TherapeuticsReleaseZipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer → BD updateSummary on the 8-K of Sep 14, 2026BD extracted 1 program update from this document → CGEM pipeline

Friday, September 1122

ZBIOZenas BioPharmaS-8Employee plan registration
ZBIOZenas BioPharmaS-3ASRAutomatic shelf registration
TENXTenax TherapeuticsSCHEDULE 13G/A13G amendment
PHIOPhio PharmaceuticalsReleasePhio Pharmaceuticals to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
OTLKOutlook TherapeuticsReleaseOutlook Therapeutics Fireside Chat from H.C. Wainwright Conference Now Available On-Demand
NRXPNRX PharmaceuticalsReleaseNRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Begins Training and Deployment of Zeta Surgical's FDA-Cleared Robotic TMS System
MBRXMoleculin BiotechReleaseMoleculin Presentation from H.C. Wainwright Conference Now Available On-Demand
KROSKeros TherapeuticsDEL AMDEL AM
IRDOpus Genetics8-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → IRD pipeline
IMUXImmunic8-KCurrent report: officer / director change
GUTSFractyl Health8-KCurrent report: listing notice → BD updateThe September 9 Nasdaq deadline passed without compliance; Fractyl filed a Panel hearing request that automatically stays delisting — buying time for the early-Q4 pivotal readout, but a 1-for-5 to 1-for-15 reverse split is now on the ballot.
GOSSGossamer BioReleaseGossamer Bio Announces Effectiveness of 1-for-80 Reverse Stock Split
GOSSGossamer Bio8-KCurrent report: holder rights modified, charter / bylaws / fiscal year, other events · EX-99.1
GHRSGH Research6-KForeign issuer report
EXELExelixis8-KCurrent report: other events → BD updateThe FDA has extended the zanzalintinib PDUFA by three months to March 3, 2027 — the second slip in this review cycle — after classifying Exelixis' updated safety and efficacy submission as a major amendment, pushing the "Christmas present" binary into Q1 2027.
ELOXEloxx PharmaceuticalsS-1Registration statement → BD updateThe EXACT Study just dosed its first two patients, confirming the Phase 2b is live — the single operational milestone I told readers to wait for. The stock has cratered -18% from the August close despite the news, and a new S-1 filed today explains part of the pressure.
ELOXEloxx PharmaceuticalsReleaseEloxx Pharmaceuticals Announces First Patients Dosed in Phase 2b EXACT Study of Exaluren in Nonsense Mutation Alport Syndrome → BD updateSummary on the S-1
CRNXCrinetics Pharmaceuticals15-12G15-12G
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
CMPSCOMPASS PathwaysReleaseStrata Mental Health Solutions Awarded U.S. Healthcare Provider Training Grant from Compass Pathways to Develop Provider Training for COMP360via aggregator
CATXPerspective TherapeuticsReleasePerspective Therapeutics Announces Acceptance of VMT-α-NET Data for Presentation at the 38th EORTC-NCI-AACR Symposium 2026BD extracted 1 program update from this document → CATX pipeline
ATAIAtai BeckleyPOSASRPOSASRSummary on the 8-K
ATAIAtai BeckleyPOS AMPost-effective amendmentSummary on the 8-K
ATAIAtai BeckleyPOS AMPost-effective amendmentSummary on the 8-K
ATAIAtai Beckley8-KCurrent report: acquisition / disposition, listing notice, holder rights modifiedThe Lilly acquisition of AtaiBeckley closed today, September 11, 2026 — shares converted to $6.75 cash + one CVR, ATAI is delisted from Nasdaq, and the story moves from active trading to CVR arithmetic. Here's the final accounting and what CVR holders watch next.
ATAIAtai Beckley25-NSEDelisting noticeSummary on the 8-K
ARTVArtiva BiotherapeuticsS-8Employee plan registration
ARTVArtiva Biotherapeutics8-KCurrent report: officer / director change, shareholder vote
AGMBAgomab TherapeuticsReleaseAgomab Announces Appointments of Marino Garcia and Dr. Naimish Patel to Board of Directors
AGMBAgomab Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1

Thursday, September 1037

VRCAVerrica PharmaceuticalsReleaseVerrica Pharmaceuticals to Present YCANTH® and VP-315 Data at Two Upcoming Dermatology Conferences
TTRXTurn TherapeuticsReleaseTurn Therapeutics to Present at Stifel 2026 Virtual Immunology and Inflammation Forum
TTRXTurn Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1 PRESS RELEASE, DATED SEPTEMBER 10, 2026
TGTXTg TherapeuticsReleaseTG Therapeutics to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
SCYXScynexisReleaseSCYNEXIS Announces Appointment of Sanjay Subramanian as Chief Financial Officer
SCYXScynexis8-KCurrent report: officer / director change, other events · EX-99.1
RYTMRhythm PharmaceuticalsReleaseRhythm Pharmaceuticals Announces New Data Presentations at the European Society for Paediatric Endocrinology Meeting
QNRXQuoin PharmaceuticalsReleaseQuoin Pharmaceuticals Releases New NETHERTON NOW Video: Aminah’s Story Featuring Laura Wright-Sexton, MD, the Physician Who First Met Her Daughter in the ICU
QNRXQuoin PharmaceuticalsDForm D (exempt offering)
QNRXQuoin Pharmaceuticals8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → QNRX pipeline
PRLDPrelude Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1
OTLKOutlook TherapeuticsReleaseOutlook Therapeutics CEO, Bob Jahr, Discusses FDA Approval and Commercial Opportunity for LYTENAVA™ in Virtual Investor CEO Connect Segment
ONCYOncolytics Biotech8-KCurrent report: other events · EX-99.1
NRSNNeuroSense TherapeuticsReleaseNeuroSense to Present at H.C. Wainwright 28th Annual Global Investment Conference
NKTXNkartaReleaseNkarta to Participate in September Investor Conferences
MAIAMAIA BiotechnologyReleaseMAIA Biotechnology Delivers Oral and Poster Presentations Showcasing Next-Generation Telomere-Targeting Cancer Therapies at IRT 2026
LGVNLongeveronSCHEDULE 13GPassive >5% holder (13G)
LEGNLegend BiotechReleaseLegend Biotech to Present Updated Long-Term and Real-World Evidence from CARVYKTI Clinical Program at the International Myeloma Society Annual MeetingBD extracted 1 program update from this document → LEGN pipeline
KROSKeros TherapeuticsS-3Shelf registration
IRONDisc Medicine8-KCurrent report: Reg FD disclosure, other events · EX-99.1
INABIN8bioReleaseIN8bio to Present at H.C. Wainwright 28th Annual Global Investment Conference
IMRXImmuneeringReleaseImmuneering to Present at the AACR Conference on Pancreatic Cancer, Highlighting Atebimetinib’s Dual Mechanism for Extended Survival
HELPHelus PharmaReleaseHelus Pharma to Participate at the Morgan Stanley 24th Annual Global Healthcare Conference in New York
HELPHelus Pharma6-KForeign issuer report · EX-99.1
EYPTEyePoint8-KCurrent report: other events · EX-99.1 → BD updateEyePoint published its full LUGANO expanded analysis at the Retina Society Annual Meeting today, adding new data that directly answers several of the unanswered scientific questions from the August 17 miss — including a 10/10 randomization simulation supporting regression-to-the-mean, GA foveal proximity imbalance, and a striking fibrosis signal — strengthening the case that LUCIA remains a genuine coin flip rather than a foregone conclusion.BD extracted 1 program update from this document → EYPT pipeline
ERASErascaReleaseErasca Announces Multiple Presentations at the Upcoming 38th EORTC-NCI-AACR SymposiumBD extracted 1 program update from this document → ERAS pipeline
DFTXDefinium TherapeuticsReleaseDefinium Therapeutics to Present Topline Data from Phase 3 Emerge and Voyage Trials Across Major Depressive Disorder and Generalized Anxiety Disorder at Psych Congress 2026BD extracted 1 program update from this document → DFTX pipeline
CRVOCervoMedReleaseCervoMed Announces Initial Results from the Phase 2a Clinical Trial of Neflamapimod in Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Have Been Accepted as a Late-Breaking Oral Session at ISFT
CRVOCervoMed8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → CRVO pipeline
CRDLCardiol TherapeuticsReleaseCardiol Therapeutics Files US$150 Million Preliminary Base Shelf Prospectus Including Additional Disclosure Following Review by Staff of the Ontario Securities Commission → BD updateSummary on the 6-K
CRDLCardiol TherapeuticsF-XF-X → BD updateSummary on the 6-K
CRDLCardiol TherapeuticsF-10F-10 → BD updateSummary on the 6-K
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 NEWS RELEASE DATED SEPTEMBER 10, 2026 → BD updateCardiol just armed a US$150M shelf — the "dilution gap is closed" thesis just got its first asterisk — while an OSC-mandated prospectus table formally locks in a Q3 2026 enrollment target and pushes the MAVERIC topline clock toward Q1–Q2 2027.
CMPSCOMPASS PathwaysReleaseCompass Pathways to Participate in Investor Conferences the Week of September 14th
CMPSCOMPASS PathwaysReleaseCompass Pathways Announces U.S. Grant Program Recipients for the Development of Post-Approval COMP360 Provider Training
CGENCompugen6-KForeign issuer report
CGEMCullinan TherapeuticsReleaseCullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung CancerBD extracted 1 program update from this document → CGEM pipeline
CADLCandel Therapeutics8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
BBOTBridgeBio Oncology TherapeuticsEFFECTRegistration effective
ADAGAdageneReleaseAdagene Announces that Third Arc Bio Has Selected First Lead Candidate under Amended Strategic Collaboration for Development of Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology → BD update
ADAGAdagene6-KForeign issuer report · EX-99.1 EXHIBIT 99.1 → BD update
ABOSAcumen PharmaceuticalsReleaseAcumen Pharmaceuticals to Hold Virtual Investor Day on September 16, 2026

Wednesday, September 953

XFORX4 Pharmaceuticals8-KCurrent report: other events · EX-99.1
XERSXeris BiopharmaReleaseXeris Hosts Webinar Detailing Its Comprehensive Development Program for XP-8121, an Investigational, Once-Weekly Subcutaneous Levothyroxine for Hypothyroidism → BD updateSummary on the 8-K
XERSXeris Biopharma8-KCurrent report: Reg FD disclosure · EX-99.1 → BD updateThe XP-8121 Phase 3 design is now fully public: n=500 (half the prior model's assumption), topline accelerated to late 2028, non-inferiority trial vs. oral levothyroxine — the program details I flagged as the #3 watch item in the August update are in, and the bear-case payer question is only partially answered.
TYRATyra BiosciencesReleaseTyra Biosciences Reports Initial Phase 2 SURF302 Results Supporting the First Potential Oral Innovation in LG IR NMIBC with Dabogratinib → BD updateSummary on the 8-KBD extracted 1 program update from this document → TYRA pipeline
TYRATyra Biosciences8-KCurrent report: other events → BD updateSURF302 Phase 2 data landed this morning — 75% BOR complete response in single-marker-lesion patients at 60 mg, clean safety, and a clear path to a registrational Phase 3 adjuvant study. The stock is down 32% from August's highs, which may be the market anchoring to the wrong CR denominator.
TTRXTurn TherapeuticsReleaseTurn Therapeutics Appoints Former CDC Director Robert R. Redfield, M.D., as Chief Scientific Officer → BD updateSummary on the 8-K
TTRXTurn Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1 PRESS RELEASE, DATED SEPTEMBER 9, 2026 → BD updateFormer CDC Director Robert Redfield joins as Chief Scientific Officer — the second ex-federal health chief added to Turn's leadership in three months, just weeks before the Q4 2026 GX-03 topline that the entire thesis has been building toward.
TENXTenax Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 1 program update from this document → TENX pipeline
PRQRProQR TherapeuticsReleaseProQR Announces First Participant Dosed in Phase 1 Study of AX-0811 and Virtual Investor and Analyst Educational Event on September 30, 2026 → BD updateSummary on the 6-K
PRQRProQR Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1 → BD updateAX-0811's Phase 1 has cleared the CTA gate and dosed its first participant — but the target engagement readout has slipped to early January 2027, not year-end 2026, which is the timeline risk the prior writeup flagged as the key tripwire for holders.
ORKAOruka TherapeuticsReleaseOruka Therapeutics to Attend the 2026 Morgan Stanley Global Healthcare Conference
NRSNNeuroSense Therapeutics6-KForeign issuer report → BD updateNeuroSense just pulled the trigger on a 1-for-20 reverse split, effective Monday September 14 — the bear-case mechanism I've flagged across four consecutive posts is now a filed fact, arriving three weeks before the September 29 Nasdaq cure deadline with 200 million shares authorized and a live ATM still printing.
NGENNervGen PharmaReleaseNervGen to Host Inaugural R&D Day on September 30, 2026
MPLTMapLight TherapeuticsS-1Registration statement
MPLTMapLight TherapeuticsReleaseMapLight Therapeutics to Participate in Upcoming Investor Conference
KZIAKazia TherapeuticsReleaseKazia Therapeutics Announces First Patient Dosed in PNOC035 Clinical Study Evaluating Paxalisib for Recurrent Pediatric AT/RT Brain Cancer
KURAKura OncologyReleaseKura Oncology Launches Caspian Therapeutics with $50 Million Financing to Advance Menin Inhibition as a Potential Disease-Modifying Approach for Diabetes → BD updateSummary on the 8-KBD extracted 1 program update from this document → KURA pipeline
KURAKura Oncology8-KCurrent report: other events → BD updateKura just spun out Caspian Therapeutics with $50M in external financing to advance KO-7246 — the menin inhibitor diabetes program I called a discovery-stage call option in the deep dive — leaving KURA's oncology cash runway completely intact while unlocking a separately capitalized shot at a disease-modifying diabetes approach.
KTTAPasithea Therapeutics8-KCurrent report: shareholder vote
KAPAKairos PharmaReleaseKairos Pharma to Present at the H.C. Wainwright 28th Annual Global Investment Conference
IXHLIncannex HealthcareReleaseIncannex Healthcare Provides Corporate Update on Clinical Progress, Intellectual Property and Capital Position
IXHLIncannex Healthcare8-KCurrent report: Reg FD disclosure · EX-99.1 PRESS RELEASE DATED AS OF SEPTEMBER 9, 2026BD extracted 2 program updates from this document → IXHL pipeline
IRDOpus GeneticsReleaseOpus Genetics Announces Positive Low Dose Cohort 1 Data from Phase 1/2 Clinical Trial of OPGx-BEST1 and Successful FDA Type C Meeting with Potential Phase 3 Dosing in 2027 → BD update
IRDOpus Genetics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updateBD extracted 1 program update from this document → IRD pipeline
IPSCCentury TherapeuticsReleaseCentury Therapeutics Appoints Joseph Truitt to Board of Directors
IPSCCentury Therapeutics8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1 EXHIBIT 99.1
INMBInmune BioReleaseINmune Bio to Present at the H.C. Wainwright Global Investment Conference
INABIN8bioReleaseIN8bio Appoints Oxana Polyakova, Ph.D., as Senior Vice President of Research & DevelopmentIN8bio just hired Oxana Polyakova — former CSO at LAVA Therapeutics and founder of Adaptate (acquired by Takeda) — as SVP R&D, a targeted signal that the INB-619 γδ TCE program the company's entire second PIPE tranche depends on is being accelerated, not shelved.
IMUXImmunic8-KCurrent report: Reg FD disclosure · EX-99.1
HELPHelus PharmaSCHEDULE 13DActivist / >5% holder (13D)
HELPHelus PharmaSCHEDULE 13DActivist / >5% holder (13D)
HELPHelus PharmaReleaseHelus Pharma to Participate at the H.C. Wainwright 28th Annual Global Investment Conference in New York
HELPHelus Pharma6-KForeign issuer report · EX-99.1
GUTSFractyl HealthReleaseFractyl Health to Participate in Upcoming September Investor Conferences
GOSSGossamer BioReleaseGossamer Bio Announces 1-for-80 Reverse Stock Split → BD updateSummary on the 8-K
GOSSGossamer Bio8-KCurrent report: other events · EX-99.1 → BD updateGossamer confirmed the reverse split ratio subscribers were waiting for: 1-for-80, landing near the severe end of the authorized range — the mechanical prerequisite for the $125M second tranche and the covenant-mandated equity raise that will define what common holders actually own going forward.
GNLXGeneluxReleaseGenelux Announces Publication of a Deep and Durable Response in a Platinum-relapsed Small Cell Lung Cancer Patient Following Systemically Delivered Olvi-Vec-Primed ImmunochemotherapyBD extracted 1 program update from this document → GNLX pipeline
EVMNEvommune8-KCurrent report: Reg FD disclosure, other events · EX-99.1BD extracted 1 program update from this document → EVMN pipeline
EVMNEvommune424B3Prospectus (resale / update)
ELDNEledon PharmaceuticalsReleaseEledon Pharmaceuticals Announces Presentation at the International Congress of The Transplantation Society
CRDLCardiol TherapeuticsReleaseCardiol Therapeutics to Participate in a Fireside Chat at the H.C. Wainwright 28th Annual Global Investment Conference → BD updateSummary on the 6-K of Sep 10, 2026
CRDLCardiol Therapeutics6-KForeign issuer report · EX-99.1 NEWS RELEASE DATED SEPTEMBER 9, 2026 → BD updateSummary on the 6-K of Sep 10, 2026
CMPSCOMPASS PathwaysReleaseCompass Pathways’ New 52-Week Topline Open-Label Data from Phase 3 COMP005 Trial Demonstrates Additional Benefit from Another COMP360 Dose in Part C Extending Durability Out to 1 Year → BD updateCOMP005's 52-week Part C data pushes COMP360's durability story to one full year — with a deepening 13-point MADRS reduction from baseline — and the retreatment model that anchors the entire commercial thesis just became year-long data, not aspiration.BD extracted 1 program update from this document → CMPS pipeline
CMMBChemomab TherapeuticsSCHEDULE 13D/A13D amendment
CADLCandel Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1
AUTLAutolus TherapeuticsReleaseAUTOLUS THERAPEUTICS ANNOUNCES FDA RMAT DESIGNATION GRANTED TO OBE-CEL FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS AND LUPUS NEPHRITIS → BD updateThe FDA just handed obe-cel its second RMAT designation — this time for SLE and lupus nephritis — validating the LUMINA registrational path at a moment when the stock has given back nearly all of its August gains.BD extracted 1 program update from this document → AUTL pipeline
ANIXAnixa BiosciencesReleaseAnixa Biosciences Interview Highlighting Breast Cancer Vaccine to Air on the RedChip Small Stocks, Big Money™ Show on Bloomberg TV
ANIXAnixa Biosciences10-QQuarterly report
AKTSAktis OncologyReleaseAKTIS ONCOLOGY TO PRESENT AT UPCOMING SEPTEMBER INVESTOR CONFERENCES
ADAGAdageneReleaseAdagene Achieves Milestone in Collaboration with Exelixis for Advancement of SAFEbody® Antibody-Drug Conjugate Candidates → BD update
ADAGAdagene6-KForeign issuer report · EX-99.1 EXHIBIT 99.1 → BD update
ACTUActuate TherapeuticsReleaseActuate Announces Promising Preclinical Data Showing Synergistic Activity of Elraglusib in Combination with RAS Inhibitors Zoldonrasib and Daraxonrasib → BD updatePreclinical data from Northwestern and Mayo Clinic shows elraglusib synergizes with both zoldonrasib and daraxonrasib — the first FDA-approved broad RAS inhibitor — in FOLFIRINOX-resistant pancreatic cancer models, sharpening the BD pitch to Revolution Medicines and the RAS-pathway cohort just as the cash runway quietly extended to October 2026.
ACTUActuate TherapeuticsReleaseActuate to Present at the H.C. Wainwright 28th Annual Global Investment Conference → BD updateSummary on the release

Tuesday, September 867

ZBIOZenas BioPharmaSCHEDULE 13G/A13G amendment
ZBIOZenas BioPharmaSCHEDULE 13GPassive >5% holder (13G)
ZBIOZenas BioPharmaReleaseZenas BioPharma to Host Obexelimab IgG4-RD Investor Event
XFORX4 Pharmaceuticals8-KCurrent report: other events · EX-99.1
VSTMVerastemReleaseVerastem Oncology to Unveil New Clinical Data Highlighting the Best-in-Class Potential of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, Across Pancreatic, Lung, and Colorectal Cancers
VRCAVerrica PharmaceuticalsReleaseVerrica Pharmaceuticals to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
VORVor BiopharmaReleaseVor Completes Enrollment of Global Phase 3 UPSTREAM MG Trial and Expands Telitacicept Global Franchise into Ocular Myasthenia Gravis → BD updateUPSTREAM MG enrollment is complete — the operational execution risk is retired, the 1H27 readout clock is officially set, and Vor just announced a new oMG registrational program that widens the pipeline-in-a-product footprint before the binary lands.
TYRATyra BiosciencesReleaseTyra Biosciences to Present at the Cantor Global Healthcare Conference
TENXTenax TherapeuticsSCHEDULE 13G/A13G amendment → BD updateSummary on the SCHEDULE 13G
TENXTenax TherapeuticsSCHEDULE 13GPassive >5% holder (13G)→ BD updateFidelity quietly cut its TENX stake from 14.9% to 1.4% as of August 31 — the same day as the ESC presentation — while ADAR1 Capital Management emerged as a new 14.0% holder. The crossover anchor I called "conviction capital" voted with its feet; a new name stepped in.
TARAProtara TherapeuticsReleaseProtara Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference
SYRESpyre TherapeuticsReleaseSpyre Announces Potential Best-in-Class SPY003 (anti-IL-23) Part A Induction Results from SKYLINE Trial, Completing Proof-of-Concept for All Three Components of its IBD Combinations → BD updateSummary on the 8-K
SYRESpyre Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe third canary sang — SPY003 hit its primary endpoint (RHI -10.0, p<0.0001) and completed proof-of-concept across all three IBD platforms, but softer clinical remission (20%) and endoscopic improvement (30%) numbers versus SPY001/SPY002 sent the stock down -15.4%. The disconnect between a "hit" and the tape's reaction is the whole story.BD extracted 1 program update from this document → SYRE pipeline
SRPTSarepta TherapeuticsReleaseSarepta Therapeutics Announces Recipients of Route 79, The Duchenne Scholarship Program, for the 2026-2027 Academic Year
SRPTSarepta TherapeuticsReleaseSarepta Therapeutics anuncia a los destinatarios de Route 79, el Programa de Becas de Duchenne, para el año académico 2026-2027
SPRBSpruce BiosciencesReleaseSpruce Biosciences to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
SANASana Biotechnology8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 1 program update from this document → SANA pipeline
RLMDRelmada Therapeutics8-KCurrent report: other events
QNRXQuoin PharmaceuticalsReleaseQuoin Pharmaceuticals Announces FDA Grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome → BD updateFDA just handed Quoin a second Rare Pediatric Disease Designation — this time for QRX003 in Peeling Skin Syndrome — potentially doubling the Priority Review Voucher math from one to two, with an aggregate non-dilutive ceiling Dr. Myers is now quoting above $300M against a market cap still in the tens of millions.BD extracted 1 program update from this document → QNRX pipeline
PTGXProtagonist TherapeuticsReleaseProtagonist Therapeutics Announces $300 Million Share Repurchase Programvia aggregator→ BD updateThe buyback I called "the single most underappreciated near-term catalyst" just landed — a $300M repurchase authorization, funded by existing cash and the incoming Takeda royalty stream, arriving three months ahead of the "by year-end" guidance in their own deck.
PMVPPMV PharmaceuticalsReleasePMV Pharmaceuticals Appoints Philip Herman as Chief Commercial OfficerPMV just hired Philip Herman as CCO — a 24-year oncology launch veteran from Repare and Y-mAbs — signaling a deliberate pivot from clinical-stage to pre-commercial, with the Q1 2027 NDA submission now eight weeks closer and the balance sheet finally fortified.
OCGNOcugen8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1
NTLAIntellia TherapeuticsReleaseIntellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)→ BD updateSummary on the 8-K
NTLAIntellia Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe FDA accepted Intellia's lonvo-z BLA with Priority Review and set a March 10, 2027 PDUFA date — the "upside surprise" catalyst I called in the September 4 update has now landed, putting the world's first in vivo CRISPR approval on a legal clock.
NRXPNRX PharmaceuticalsReleaseNRx Pharmaceuticals to Participate in Upcoming Investor Conferences
NKTXNkartaReleaseNkarta to Present Initial Autoimmune Clinical Data for NKX019 at American College of Rheumatology (ACR) Convergence 2026 → BD updateNkarta just confirmed ACR Convergence (Nov 8–11) as the venue for the first NKX019 efficacy data — and the CEO's word choice ("early efficacy we're seeing") implies the data exists and is positive, explaining today's +31.3% stock surge.BD extracted 1 program update from this document → NKTX pipeline
NKTRNektar Therapeutics8-KCurrent report: Reg FD disclosure
NGNENeurogeneReleaseNeurogene to Participate in H.C. Wainwright 28th Annual Global Investment Conference
NBPNovaBridge BiosciencesReleaseNovaBridge Appoints Martin Dewhurst to Board of Directors as an Independent Director
NBPNovaBridge Biosciences6-KForeign issuer report
NBPNovaBridge Biosciences6-KForeign issuer report · EX-99.1
LENZLENZ TherapeuticsSCHEDULE 13G/A13G amendment
LCTXLineage Cell TherapeuticsReleaseLineage Cell Therapeutics Announces Issuance of Patent Underlying Its AlloSCOPE™ 5D Manufacturing Platform
KYMRKymera TherapeuticsSCHEDULE 13G/A13G amendment
KURAKura OncologyReleaseKura Oncology Appoints Jennifer Fulk as Chief Financial Officer
KURAKura Oncology8-KCurrent report: officer / director change
KROSKeros Therapeutics8-KCurrent report: other events · EX-99.1
KPRXKiora PharmaceuticalsReleaseKiora Pharmaceuticals Appoints Keith J. Lane as Executive Vice President of Global Clinical Development and Regulatory Affairs → BD updateSummary on the 8-K
KPRXKiora Pharmaceuticals8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1 → BD updateThe CDO succession watch item flagged in April is now resolved: Kiora hired Keith Lane, a 20-year ophthalmic drug development veteran with 12 global Phase 3 studies under his belt, as EVP of Clinical Development — closing the leadership gap ahead of the global KIO-301 Phase 3.
INBXInhibrx BiosciencesReleaseInhibrx's INBRX-106 Nearly Doubles Response Rate and Achieves Interim Median PFS of 9.6 months in Phase 2 HNSCC Study → BD updateSummary on the 8-K
INBXInhibrx Biosciences8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateThe HexAgon Phase 2 primary endpoint just printed the cleanest OX40 data ever generated in a randomized study — 9.6 months median PFS versus 4.9 months for pembrolizumab alone, with an HPV+ subgroup signal so strong (80% cORR, 90% PFS6, median PFS not reached) that Inhibrx is now pursuing accelerated approval rather than jumping straight to Phase 3.BD extracted 1 program update from this document → INBX pipeline
GPCRStructure TherapeuticsReleaseStructure Therapeutics Reports Positive Clinical Data Across Oral Small Molecule Amylin and GLP-1 Programs for Chronic Weight Management → BD updateSummary on the 8-K
GPCRStructure Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1 → BD updateGPCR's most anticipated catalyst just landed — first human data for its oral amylin asset ACCG-2671 plus 72-week durability confirmation for aleniglipron — and the stock is down 23% from the August high. The data looks good. The market disagrees. Here's why.BD extracted 2 program updates from this document → GPCR pipeline
GLUEMonte Rosa TherapeuticsReleaseMonte Rosa Therapeutics Announces Milestone Achievement Associated with Initiation of Phase 2 Clinical Study for VAV1-directed Molecular Glue Degrader MRT-6160 (DDY391)→ BD updateSummary on the 8-K
GLUEMonte Rosa Therapeutics8-KCurrent report: Reg FD disclosure, other events · EX-99.1 → BD updateNovartis has formally triggered the first milestone on the $2.1B ladder — a $50M payment tied to first patient visit in the Sjögren's Phase 2 — while GLUE shares are down 9% since the last update, creating a classic signal-vs.-noise divergence worth noting.
FBRXForte BiosciencesSCHEDULE 13G/A13G amendment
FBRXForte Biosciences15-12G15-12G
FBRXForte Biosciences15-12G15-12G
FBRXForte Biosciences15-12G15-12G
FBIOFortress BiotechReleaseJourney Medical Corporation to Participate in September 2026 Investor Conferences
FBIOFortress BiotechReleaseFortress Biotech to Present at the H.C. Wainwright 28th Annual Global Investment Conference
EYPTEyePointSCHEDULE 13GPassive >5% holder (13G)
EVMNEvommuneReleaseEvommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Atopic Dermatitis → BD updateBD extracted 2 program updates from this document → EVMN pipeline
ERASErascaReleaseErasca to Present at the Morgan Stanley 24th Annual Global Healthcare Conference
DYNDyne TherapeuticsReleaseDyne Therapeutics to Present Additional One-Year Clinical Data from Phase 1/2 ACHIEVE Trial of Z-Basivarsen (DYNE-101) for Myotonic Dystrophy Type 1 (DM1) at Upcoming Medical MeetingsBD extracted 1 program update from this document → DYN pipeline
DFTXDefinium TherapeuticsReleaseDefinium Therapeutics Receives Breakthrough Therapy Designation for DT120 (lysergide) Orally Disintegrating Tablet (ODT) in Major Depressive Disorder (MDD) Following Positive Phase 3 Results → BD updateSummary on the 8-K
DFTXDefinium Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateThe FDA just handed Definium its second Breakthrough Therapy Designation — this time for MDD, on the strength of the Emerge Phase 3 data — as the stock sits 10.7% below the Voyage-hit high with Panorama weeks away.BD extracted 1 program update from this document → DFTX pipeline
CRVOCervoMedReleaseCervoMed to Participate in September Investor Conferences
CMPSCOMPASS PathwaysReleaseCompass Pathways to Debut U.S. HCP Education Campaign and Present New HEOR Data at Psych Congress 2026
CLDXCelldex TherapeuticsReleaseCelldex to Present at Upcoming Investor Conference
CGTXCognition TherapeuticsReleaseCognition Therapeutics to Present at H.C. Wainwright Global Investment Conference
CGENCompugenReleaseCompugen to Participate in a Fireside Chat at the H.C. Wainwright 28th Annual Global Investment Conference
CATXPerspective Therapeutics8-KCurrent report: other events · EX-99.1BD extracted 2 program updates from this document → CATX pipeline
BLTEBelite BioReleaseBelite Bio Announces Submission of New Drug Application to the Ministry of Health, Labour, and Welfare in Japan under the Sakigake Designation System for Tinlarebant for the Treatment of Stargardt Dis → BD updateSummary on the 6-KBD extracted 1 program update from this document → BLTE pipeline
BLTEBelite Bio6-KForeign issuer report · EX-99.1 EXHIBIT 99.1 → BD updateBelite Bio filed a Japan NDA for tinlarebant under Sakigake designation — the same expedited pathway that could make it the first-ever ophthalmology drug approved under Sakigake — adding a second regulatory clock to the February 2027 FDA PDUFA and a 9,500-patient Japan market to the commercial case.
BIOABioAge LabsReleaseBioAge Labs Announces First Participant Dosed in QUELL-DME, a Phase 2 Trial of BGE-102, a Novel Oral NLRP3 Inhibitor, in Diabetic Macular Edema → BD updateQUELL-DME just dosed its first participant — a larger, harder-endpoint Phase 2 trial than the prior writeup described — while QUELL-CV quietly confirms full enrollment ahead of the H2 2026 binary. The pipeline is tracking, but the stock has shed another 14% since August.BD extracted 1 program update from this document → BIOA pipeline
BEAMBeam TherapeuticsReleaseBeam Therapeutics Presents Updated Clinical Data from the Phase 1/2 Trial of BEAM-302 in Alpha-1 Antitrypsin Deficiency (AATD) at the European Respiratory Society (ERS) Congress 2026 → BD updateThe ERS late-breaker landed: BEAM-302's single-dose data held clean across 29 patients and up to 18 months of follow-up — the hepatotoxicity overhang that defined the bear case looks materially narrower than it did five weeks ago, and the pivotal cohort is already dosing.
BCTXBriaCell TherapeuticsReleaseBriaCell’s Pivotal Phase 3 Metastatic Breast Cancer Study Expands to Leading Cancer Centervia aggregator
BBOTBridgeBio Oncology TherapeuticsReleaseBBOT Announces New BBO-8520 Data; Highlights Strategic Focus on 2L+ NSCLC BBO-8520 Combination as Well as BBO-11818 and BBO-10203 Combinations in KRAS-Mutant Cancers → BD updateSummary on the 8-KBD extracted 2 program updates from this document → BBOT pipeline
BBOTBridgeBio Oncology TherapeuticsEFFECTRegistration effective → BD updateSummary on the 8-K
BBOTBridgeBio Oncology Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateThe 2H 2026 data has arrived: BBO-8520 monotherapy holds its ORR at scale (63%, n=41) with a 100% disease control rate and zero Grade 3 liver events, while the pembrolizumab combo in inhibitor-experienced NSCLC hits 75% ORR at the lead dose — and BBOT just declared its strategic endgame.BD extracted 5 program updates from this document → BBOT pipeline
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ATAIAtai Beckley8-KCurrent report: shareholder vote
ARTVArtiva BiotherapeuticsReleaseArtiva Biotherapeutics Provides Update on Planned AlloNK® Data Disclosures and Development Milestones for the Remainder of 2026Artiva just set the clock on its most consequential near-term data release: ≥20 refractory RA patients with ≥6 months of follow-up — nearly 3x the n=7 that drove the 76% re-rating in May — arriving in H2 2026, alongside Phase 3 enrollment initiation. The 71% ACR50 is about to get its first real stress test.BD extracted 1 program update from this document → ARTV pipeline
APGEApogee TherapeuticsSCHEDULE 13D/A13D amendment
AMLXAmylyx PharmaceuticalsReleaseAmylyx Pharmaceuticals to Present at the 24th Annual Morgan Stanley Global Healthcare Conference
AMLXAmylyx Pharmaceuticals8-KCurrent report: material agreement
ACETAdicet Bio8-KCurrent report: Reg FD disclosure · EX-99.1BD extracted 1 program update from this document → ACET pipeline

Friday, September 419

ZBIOZenas BioPharmaReleaseZenas BioPharma to Present at Upcoming Healthcare Investor Conferences
VORVor BiopharmaS-3ASRAutomatic shelf registration
TYRATyra BiosciencesReleaseTyra Biosciences to Host Conference Call on Initial Results of Oral Dabogratinib from the SURF302 Phase 2 Study for IR NMIBC on September 9, 2026BD extracted 1 program update from this document → TYRA pipeline
RNTXRein Therapeutics8-KCurrent report: Reg FD disclosure · EX-99.1
PALIPalisade BioReleaseGut-Targeted Inhibition of Phosphodiesterase 4 with PALI-2108 Demonstrates Early Endoscopic and Biomarker Improvements in Fibrostenotic Crohn’s Disease: Results From a Phase 1b StudyBD extracted 1 program update from this document → PALI pipeline
PALIPalisade BioReleaseThe Microbiome-Activated Phosphodiesterase (PDE)-4 Inhibitor, PALI-2108 Leads to Rapid Clinical and Histologic Improvement in Moderate-to-Severe Ulcerative Colitis: A Phase1a/1b Study
PALIPalisade BioReleasePALI-2108, a Next-Generation Oral PDE4 Inhibitor Prodrug, Demonstrates Localized Ileocolonic Exposure with Favorable Tolerability in IBD
PALIPalisade BioReleaseDevelopment of Mucosal Transcriptomic Signatures to Predict Response to the Microbiome-Activated Phosphodiesterase (PDE)-4 Inhibitor PALI-2108 in Ulcerative Colitis
PALIPalisade BioReleaseMicrobiome Beta-Glucuronidase Activity Does Not Limit Bioconversion or Pharmacokinetic Consistency of the Colon-Targeted PDE4 Prodrug PALI-2108 in Ulcerative Colitis
NTLAIntellia TherapeuticsReleaseIntellia Therapeutics to Present at Morgan Stanley 24th Annual Global Healthcare Conference → BD updateSummary on the 8-K
NTLAIntellia TherapeuticsReleaseIntellia Therapeutics Secures Non-Dilutive Debt Facility with OrbiMed for up to $400 Million → BD updateSummary on the 8-K
NTLAIntellia Therapeutics8-KCurrent report: material agreement, debt / obligation, Reg FD disclosure · EX-99.1 → BD updateIntellia just closed a $400M non-dilutive debt facility with OrbiMed — structured so that the milestones unlocking the remaining $325M are exactly the lonvo-z catalysts the thesis has been tracking, but the security interest over all assets (including contested IP) introduces a new risk layer worth unpacking.
IONSIonis Pharmaceuticals8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1
IONSIonis Pharmaceuticals8-KCurrent report: Reg FD disclosure, other events · EX-99.1 EXHIBIT 99.1
INBXInhibrx BiosciencesReleaseInhibrx To Host Webcast Presentation to Provide Primary Endpoint Results for INBRX-106 Phase 2 First-Line HNSCC Study → BD updateInhibrx just set the clock: the HexAgon Phase 2 PFS readout — the binary I called the valuation's entire spine — drops Tuesday, September 8 at 5:00 a.m. PT via live webcast, four trading days away.BD extracted 1 program update from this document → INBX pipeline
HURATuHURA Biosciences8-KCurrent report: debt / obligation
HROWHarrow8-KCurrent report: officer / director change
GOSSGossamer BioReleaseGossamer Bio to Present at Cantor Global Healthcare Conference
GOSSGossamer BioDForm D (exempt offering)
ELDNEledon PharmaceuticalsS-8Employee plan registration
CATXPerspective TherapeuticsSCHEDULE 13D/A13D amendment → BD updateLantheus Holdings quietly sold ~237K CATX shares over four days (Aug 31–Sep 3) at ~$3.10/share and has now formally authorized itself to sell more — a notable shift from a 10% strategic radiopharma holder that changes the float narrative I've been writing about all year.

Thursday, September 356

XENEXenon PharmaceuticalsReleaseXenon to Present at Wells Fargo Healthcare Conference
WVEWave Life SciencesReleaseWave Life Sciences to Present at Cantor 2026 Global Healthcare Conference
TGTXTg TherapeuticsReleaseTG Therapeutics to Participate in the Cantor Global Healthcare Conference
TECXTectonic TherapeuticReleaseWATERTOWN, Mass., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”), a clinical stage biotechnology company focused on the discovery and development of therapeu
SYRESpyre TherapeuticsReleaseSpyre Therapeutics to Participate in Upcoming September Investor Conferences
SMMTSummit Therapeutics8-KCurrent report: other events · EX-99.1HARMONi-2's preplanned OS analysis confirms ivonescimab monotherapy beats pembrolizumab monotherapy on survival in PD-L1-positive NSCLC — the first time Keytruda has lost a head-to-head survival comparison in a randomized Phase III — sending SMMT up 17.3% to $17.13 and resetting the thesis into the September 15 WCLC catalyst 12 days out.BD extracted 1 program update from this document → SMMT pipeline
RNACCartesian TherapeuticsReleaseCartesian Therapeutics to Participate in Upcoming Investor Conferences
REPLReplimune GroupReleaseReplimune to Present at the Cantor Global Healthcare Conference 2026
PCVXVaxcyteReleaseVaxcyte Appoints Chief Medical Officer and Chief Legal Officer; Narrows Guidance for Expected VAX-31 OPUS-1 Topline Data → BD updateSummary on the 8-K
PCVXVaxcyte8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1 → BD updateVaxcyte just pulled OPUS-1 topline forward to end of October — the Q4 binary is now a Q4-early binary — and hired the former Pfizer CMO for Vaccines who personally ran the Prevnar 13 and Prevnar 20 programs to lead its clinical organization into the readout.BD extracted 1 program update from this document → PCVX pipeline
PALIPalisade BioReleasePalisade Bio to Participate in Upcoming Investor Conferences
NVCTNuvectis PharmaReleaseNuvectis Pharma To Participate in Upcoming Investor Conferencesvia aggregator
MISTMilestone PharmaceuticalsReleaseMilestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States → BD updateSummary on the 8-K
MISTMilestone Pharmaceuticals8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1 → BD updateChina's NMPA just approved etripamil nasal spray — the first approval outside the U.S. — triggering a $2M milestone and unlocking up to $98M more from Everest Medicines. The JX02002 China trial independently replicated the RAPID result (HR=3.002, p=0.0005), and the stock woke up +7.6% today.BD extracted 1 program update from this document → MIST pipeline
MDNAFMedicenna TherapeuticsReleaseMedicenna to Present at the H.C. Wainwright 28th Annual Global Investment Conference
LQDALiquidia8-KCurrent report: other events · EX-99.1 EXHIBIT 99.1
LGVNLongeveronReleaseLongeveron to Present at the H.C. Wainwright 28th Annual Global Investment Conference
LBRXLB Pharmaceuticals8-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
LBRXLB Pharmaceuticals424B3Prospectus (resale / update)
KTTAPasithea TherapeuticsReleasePasithea Therapeutics Announces Participation in Two September 2026 Investor Conferences
INSMInsmedReleaseInsmed to Present Data Across Its Respiratory Portfolio, Including New Late-Breaking ARIKAYCE® (amikacin liposome inhalation suspension) Results From Phase 3b ENCORE Study at the European RespiratoryBD extracted 3 program updates from this document → INSM pipeline
IMVTImmunovant8-KCurrent report: shareholder vote
IMRXImmuneeringReleaseImmuneering to Participate in Upcoming Investor Conferences
HELPHelus PharmaReleaseHelus Pharma to Participate at the 2026 Cantor Global Healthcare Conference in New York
HELPHelus Pharma6-KForeign issuer report · EX-99.1
GRCEGrace TherapeuticsReleaseGrace Therapeutics to Participate in the H.C. Wainright 28th Annual Global Investment Conference
GPCRStructure TherapeuticsReleaseStructure Therapeutics to Participate in Upcoming Healthcare Investor Conferences
GOSSGossamer BioPRE 14APRE 14A
GOSSGossamer Bio8-KCurrent report: charter / bylaws / fiscal year
ELDNEledon PharmaceuticalsReleaseEledon Pharmaceuticals Announces Islet Cell Transplantation IND Submission, First Patients Enrolled in Multiple Transplant Programs, and Reaffirms Plan to Initiate Phase 3 Kidney Transplantation Trial → BD updateEledon just checked one of my three explicit "add only on" boxes — the company-sponsored islet IND is filed — while simultaneously confirming Q4 2026 LEGACY Phase 3 initiation and opening compassionate-use programs in two new patient populations. The stock is down ~21% from my writeup price, which makes the timing matter.BD extracted 1 program update from this document → ELDN pipeline
EIKNEikon TherapeuticsReleaseEikon Therapeutics Appoints Ching-Pin Chang, M.D., Ph.D. as Executive Vice President and Chief Scientific Officer
DYNDyne TherapeuticsReleaseDyne Therapeutics to Present Preclinical Data for Multiple Development Candidates for Duchenne Muscular Dystrophy (DMD) at 27th Annual NMSG Scientific Meeting
DBVTDBV TechnologiesReleaseDBV Technologies to Participate in Upcoming September Investor Conferences
CRVSCorvus PharmaceuticalsReleaseCorvus Pharmaceuticals to Present at the 2026 Cantor Global Healthcare Conference
CNTBConnect BiopharmaReleaseConnect Biopharma to Present at the H.C. Wainwright 28th Annual Global Investment Conference
CLYMClimb BioReleaseClimb Bio Announces CLYM116 Phase 1 Data Demonstrating Prolonged Half-Life and Best-In-Class APRIL Suppression Supporting Every-12-Week Dosing in IgA Nephropathy → BD updateSummary on the 8-K
CLYMClimb Bio8-KCurrent report: Reg FD disclosure · EX-99.1 → BD updateThe CLYM116 sweeper mechanism just delivered its money number: a ~29-day half-life (3x sibeprenlimab), >90% APRIL suppression from a single dose, and 60-75% IgA knockdown held through 12 weeks — the half-life reveal I told readers to set their alarms for has landed clean, and Phase 3 is now a 2027 target.BD extracted 1 program update from this document → CLYM pipeline
CLNNCleneReleaseClene to Present at Upcoming September Investor Conferences
CCCCC4 TherapeuticsReleaseC4 Therapeutics to Present New Biomarker Data on the Immunomodulatory Effects of Cemsidomide in Combination with Dexamethasone from its Phase 1 Relapsed/Refractory Multiple Myeloma Trial at the 23rd IBD extracted 1 program update from this document → CCCC pipeline
CBIOCrescent BiopharmaReleaseCrescent Biopharma to Present at September Investor Conferences
BMEABiomea FusionReleaseBiomea Fusion to Participate in Upcoming Investor Conferences
ATHEAlterity TherapeuticsReleaseAlterity Therapeutics to Participate in a Fireside Chat at the Cantor Global Healthcare Conference 2026via aggregator
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ARVNArvinasReleaseArvinas to Participate in Upcoming Investor Conferences
APVOAptevo TherapeuticsReleaseAptevo Reports 93% Clinical Benefit Rate with Mipletamig Triplet in Difficult-to-Treat TP53-Mutated Frontline AML → BD updateSummary on the 8-K
APVOAptevo Therapeutics8-KCurrent report: other events · EX-99.1 → BD updateAptevo dropped a TP53 subgroup data release today — 79% CR/CRi in 14 evaluable patients vs. a published 41% ven/aza benchmark — on the exact same day the 6.4M-share warrant resale registration went effective, explaining the -41.8% stock collapse since August 14 and crystallizing the core tension: the most interesting clinical signal yet, arriving into the worst possible financing structure.BD extracted 1 program update from this document → APVO pipeline
APVOAptevo Therapeutics424B4Prospectus (IPO / follow-on)→ BD updateSummary on the 8-K
APGEApogee TherapeuticsSCHEDULE 13D/A13D amendment
APGEApogee TherapeuticsS-8 POSEmployee plan registration (post-effective)
APGEApogee TherapeuticsS-8 POSEmployee plan registration (post-effective)
APGEApogee TherapeuticsS-8 POSEmployee plan registration (post-effective)
APGEApogee TherapeuticsS-8 POSEmployee plan registration (post-effective)
APGEApogee TherapeuticsS-8 POSEmployee plan registration (post-effective)
APGEApogee TherapeuticsReleaseAbbVie Completes Acquisition of Apogee Therapeuticscompany site may be offline after the acquisition
APGEApogee TherapeuticsPOSASRPOSASR
APGEApogee Therapeutics8-KCurrent report: agreement terminated, acquisition / disposition, listing notice
APGEApogee Therapeutics25-NSEDelisting notice
ANIXAnixa BiosciencesReleaseAnixa Biosciences to Present at the Nasdaq & LD Micro Inaugural SF Summit on September 9, 2026
ALTAltimmuneReleaseAltimmune to Participate in the Wells Fargo 21st Annual Healthcare Conference
AGMBAgomab TherapeuticsReleaseAgomab to Participate in Upcoming Investor Conferences
ADCTADC TherapeuticsReleaseADC Therapeutics to Participate in the 2026 Cantor Global Healthcare Conference
ACRSAclaris TherapeuticsReleaseAclaris Therapeutics to Participate in the 2026 Cantor Global Healthcare Conference
ACIUAC Immune6-KForeign issuer report · EX-99.1 EXHIBIT 99.1BD extracted 1 program update from this document → ACIU pipeline

Wednesday, September 245

ZNTLZentalis PharmaceuticalsReleaseZentalis Pharmaceuticals to Participate in Upcoming Investor Conferences
XNCRXencorReleaseXencor to Present at the 2026 Cantor Global Healthcare Conference
VTVTvTv TherapeuticsReleasevTv Therapeutics to Participate in September Investor Conferences
VSTMVerastemReleaseVerastem Oncology to Participate in Upcoming September Investor Conferences
VRDNViridian TherapeuticsReleaseViridian Therapeutics to Participate in the Wells Fargo 21st Annual Healthcare Conference
VNDAVanda PharmaceuticalsReleaseVanda Pharmaceuticals Announces Participation at September 2026 Investor Conferences
VKTXViking TherapeuticsReleaseViking Therapeutics to Participate at Upcoming Investor Conferences
TLXTelix Pharmaceuticals6-KForeign issuer report · EX-99.1
SMMTSummit TherapeuticsReleaseIvonescimab Monotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in HARMONi-2 Study Conducted by Akeso in → BD updateAkeso's HARMONi-2 just delivered what no trial has done before: ivonescimab monotherapy beat Keytruda monotherapy on overall survival in PD-L1-positive NSCLC — the third OS win over an approved checkpoint inhibitor, 73 days before the FDA PDUFA.BD extracted 1 program update from this document → SMMT pipeline
SLSSELLAS Life Sciences GroupReleaseSELLAS Life Sciences to Present Preclinical Data on SLS009 in Pancreatic Ductal Adenocarcinoma at the 2026 AACR Conference on Pancreatic Cancer
SGMTSagimet BiosciencesReleaseSagimet Biosciences Announces Participation in Two Upcoming Investor Conferences
RVMDRevolution MedicinesReleaseNew England Journal of Medicine Publishes Phase 1/2 Clinical Data on Revolution Medicines’ RASONQUE™ (daraxonrasib) in Metastatic Non-Small Cell Lung CancerBD extracted 1 program update from this document → RVMD pipeline
RCKTRocket Pharmaceuticals25-NSEDelisting notice
RAREUltragenyx PharmaceuticalReleaseUltragenyx Announces Phase 3 Aspire results in Angelman Syndrome → BD updateSummary on the 8-KBD extracted 1 program update from this document → RARE pipeline
RAREUltragenyx Pharmaceutical8-KCurrent report: other events → BD updateThe Phase 3 Aspire trial for apazunersen (GTX-102) in Angelman syndrome failed both the primary and key secondary endpoints today — the crown jewel missed, the 2026 bull case is broken, and more cost cuts are coming.
QUREuniQureReleaseuniQure Announces Submission of Biologics License Application for Ifezuntirgene Inilparvovec (AMT-130) in Huntington’s Diseasevia aggregator→ BD updateSummary on the 8-K
QUREuniQure8-KCurrent report: Reg FD disclosure · EX-99.1 → BD updateuniQure filed the AMT-130 BLA with the FDA today — requesting priority review that could cut the clock to ~6 months — and simultaneously submitted the UK MHRA MAA, completing the dual regulatory filing management telegraphed all summer. The four-year cUHDRS readout, still due before end of Q3, is now the only gate left before the FDA's 60-day filing review begins in earnest.BD extracted 1 program update from this document → QURE pipeline
PTGXProtagonist TherapeuticsReleaseProtagonist Therapeutics to Participate in Two Investment Bank Conferences in September 2026via aggregator
PRQRProQR TherapeuticsReleaseProQR to Participate in Upcoming Investor Conferences in September 2026
PMVPPMV Pharmaceuticals8-KCurrent report: material agreement, other events · EX-99.1
PMVPPMV Pharmaceuticals424B5Prospectus supplement (offering)
NAMSNewAmsterdam PharmaReleaseNewAmsterdam Pharma to Participate at Upcoming Investor Conferences in September
MISTMilestone PharmaceuticalsReleaseMilestone Pharmaceuticals to Present at Upcoming Investor Conferences
LXEOLexeo TherapeuticsReleaseLexeo Therapeutics to Participate in Upcoming Investor Conferences in Septembercompany site may be offline after the acquisition
KYMRKymera TherapeuticsReleaseWATERTOWN, Mass., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicine
IRDOpus GeneticsReleaseOpus Genetics to Present OPGx-BEST1 Cohort 1 Clinical Data in Investor Webcast and at Upcoming Leading Ophthalmology Conferences → BD updateThe BEST1 Cohort 1 topline data — the binary I've been flagging since the original deep dive — drops September 9 at 8 a.m. ET. Here's what to watch for and how to read the print when it lands.BD extracted 1 program update from this document → IRD pipeline
IMVTImmunovantRelease2026 Annual Meeting of Stockholders
IMUXImmunicReleaseImmunic to Host Virtual Relapsing Multiple Sclerosis R&D Day on September 9, 2026
IMNMImmunomeReleaseImmunome to Present at the H.C. Wainwright 28th Annual Global Investment Conference
GERNGeronReleaseGeron to Present at Upcoming Investor Conferences
EYPTEyePointReleaseEyePoint Announces Participation at Upcoming Investor Conferences and Scientific MeetingBD extracted 1 program update from this document → EYPT pipeline
DBVTDBV TechnologiesReleaseInformation Regarding the Total Number of Voting Rights and Total Number of Shares of the Company as of August 31, 2026
COGTCogent Biosciences8-KCurrent report: material agreement → BD updateCogent just signed a five-year commercial supply agreement with Hovione — the second manufacturer for bezuclastinib drug product — directly retiring the single-source API risk I've called the "silent killer" in every update since May, with 89 days left to the GIST PDUFA.
CMPSCOMPASS PathwaysReleaseCompass Pathways Recognized as a 2026 Fierce 50 Breakthrough Honoree
CGONCG OncologyReleaseCG Oncology to Present at Upcoming Investor Conferences in September
BIOABioAge LabsReleaseBioAge Labs to Present at Upcoming Investor Conferences
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ARTVArtiva BiotherapeuticsReleaseArtiva Biotherapeutics to Participate in Upcoming Investor Conferences in September
APVOAptevo TherapeuticsEFFECTRegistration effective
ANNXAnnexonReleaseAnnexon to Participate in Upcoming September Investor Conferences
ALLOAllogene TherapeuticsReleaseAllogene Therapeutics Announces Retirement of Chief Financial Officer Geoffrey Parker → BD updateSummary on the 8-K
ALLOAllogene Therapeutics8-KCurrent report: officer / director change → BD updateCFO Geoffrey Parker announced his retirement effective November 6, 2026 — the second C-suite exit in three months at Allogene, following the David Chang CEO succession. The thesis is intact, but back-to-back top-of-org departures heading into the Q4 ALLO-329 readout demand a read of the tea leaves.
ACRVAcrivon TherapeuticsReleaseAcrivon Therapeutics to Present at the 2026 Cantor Global Healthcare Conference
ACETAdicet BioReleaseAdicet Bio to Participate in Fireside Chat at H.C. Wainwright 28th Annual Global Investment Conference
ABOSAcumen PharmaceuticalsReleaseAcumen Pharmaceuticals to Participate in Upcoming Investor Conferences

Tuesday, September 152

VYGRVoyager TherapeuticsReleaseVoyager to Present at Upcoming Investor Conferences
VORVor BiopharmaReleaseVor Bio To Participate in Upcoming September Conferences
VERAVera TherapeuticsReleaseVera Therapeutics to Participate at Upcoming Investor Conferences
UNCYUnicycive TherapeuticsReleaseUnicycive Therapeutics to Present at the H.C. Wainwright 28th Annual Global Investment Conference
TNGXTango TherapeuticsReleaseTango Therapeutics to Participate in the 2026 Cantor Global Healthcare Conference
TLXTelix Pharmaceuticals6-KForeign issuer report · EX-99.1
TENXTenax TherapeuticsReleaseTenax Therapeutics to Participate in the 2026 Cantor Global Healthcare Conference
SCYXScynexisReleaseSCYNEXIS to Participate in Upcoming Investor Conferencesvia aggregator
SANASana BiotechnologyReleaseSana Biotechnology to Present at September 2026 Investor Conferences
SABSSAB BiotherapeuticsReleaseSAB BIO to Participate in Upcoming Investor Conferences
RVMDRevolution Medicines8-KCurrent report: material agreement, debt / obligation
RLMDRelmada TherapeuticsReleaseRelmada Therapeutics to Participate at the Wells Fargo 21st Annual Healthcare Conferencevia aggregator
RLAYRelay TherapeuticsReleaseRelay Therapeutics to Participate in Two Upcoming Investor Conferences in September
RAREUltragenyx PharmaceuticalReleaseUltragenyx Announces the Publication of a Successful 96-Week Randomized, Placebo-Controlled Trial with Crossover Treatment of GENGLYCOS™ (also known as DTX401) AAV Gene Therapy in GSDIa in The JournalBD extracted 1 program update from this document → RARE pipeline
PMNProMIS NeurosciencesReleaseProMIS Neurosciences to Participate in Upcoming Conferences and Events in September
PCSAProcessa PharmaceuticalsReleaseProcessa Pharmaceuticals to Participate in Upcoming Investor Conferences
OCGNOcugenReleaseOcugen Announces First Patient Dosed in Phase 3 Registrational Trial of OCU410 Modifier Gene Therapy for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration → BD updateArMaDa3 just dosed its first patient — the execution checkpoint I'd been watching since August 6 hit exactly on schedule, and Genead's Phase 3 debut lands two weeks before the September 21 reserved-share vote that could finally unlock the convertible's stock-settlement mechanics.BD extracted 1 program update from this document → OCGN pipeline
NRIXNurix TherapeuticsReleaseNurix Therapeutics to Participate in Upcoming September Investor Conferences
LEGNLegend BiotechReleaseLegend Biotech to Participate in the Morgan Stanley Global Healthcare Conference
KZIAKazia TherapeuticsReleaseKazia Therapeutics Reports Preclinical Data Showing Paxalisib Reprograms Immunotherapy-Resistant MSS/pMMR Colorectal Cancer and Enhances Response to Immunotherapy
KZIAKazia TherapeuticsReleaseKazia Therapeutics Expands Paxalisib Clinical Trial into HR+/HER2- Breast Cancer, Supported by Preclinical Data Showing Strong Clinical Activity and Safety in HR+ Breast Cancervia aggregator
KZIAKazia Therapeutics6-KForeign issuer report · EX-99.1 PRESS RELEASE DATED SEPTEMBER 1, 2026BD extracted 1 program update from this document → KZIA pipeline
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KZIAKazia Therapeutics424B3Prospectus (resale / update)
KYTXKyverna TherapeuticsReleaseCompany Statement on Miv-cel's Favorable Safety Profile → BD updateKyverna broke silence today with a reactive safety statement defending miv-cel's tolerability profile against unnamed "third-party reports" — the first crack in the CAR-T safety narrative to surface during the rolling BLA window, and exactly the kind of event the prior writeup's bear case warned could materialize.BD extracted 2 program updates from this document → KYTX pipeline
KYMRKymera TherapeuticsReleaseEnrollment completed in KT-621 BROADEN2 Phase 2b AD trial with topline data expected by year-end 2026; Phase 3 trials in AD planned to initiate by mid-2027 KT-621 BREADTH Phase 2b asthma trial ongoingBD extracted 1 program update from this document → KYMR pipeline
KURAKura OncologyReleaseKura Oncology to Participate in Three Investor Conferences in September
JBIOJade BiosciencesReleaseSEPTEMBER 1, 2026 Jade Biosciences to Participate in Upcoming Conferences
IVVDInvivyd8-KCurrent report: officer / director change, other events · EX-99.1
IMUXImmunicReleaseImmunic Appoints Chitrang Davé as Chief Data and Digital Officer
HELPHelus PharmaS-8Employee plan registration
HELPHelus PharmaDForm D (exempt offering)
GLUEMonte Rosa TherapeuticsReleaseMonte Rosa Therapeutics to Participate in Upcoming Investor Conferences
FBRXForte BiosciencesEFFECTRegistration effective
FBRXForte BiosciencesEFFECTRegistration effective
FBRXForte BiosciencesEFFECTRegistration effective
FBRXForte BiosciencesEFFECTRegistration effective
FBRXForte BiosciencesEFFECTRegistration effective
FBRXForte BiosciencesEFFECTRegistration effective
FBIOFortress BiotechSCHEDULE 13GPassive >5% holder (13G)
EXELExelixisReleaseExelixis to Webcast Fireside Chats as Part of Upcoming Investor Conferences in September
ENTAEnanta PharmaceuticalsReleaseEnanta Pharmaceuticals to Participate in September Investor Conferences
CYDYCytoDynReleaseCytoDyn Closes $16.5 Million Financing to Fund Continued Development of Leronlimab
CTMXCytomX TherapeuticsReleaseCytomX Therapeutics to Present at Upcoming September Investor Conferences
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsS-8 POSEmployee plan registration (post-effective)
CRNXCrinetics PharmaceuticalsReleaseVertex Completes Acquisition of Crinetics Pharmaceuticals and Announces Expansion of Executive Leadership Teamvia aggregatorcompany site may be offline after the acquisition
CRNXCrinetics PharmaceuticalsPOSASRPOSASR
CRNXCrinetics PharmaceuticalsPOSASRPOSASR
CRNXCrinetics Pharmaceuticals8-KCurrent report: agreement terminated, acquisition / disposition, listing notice
CRNXCrinetics Pharmaceuticals25-NSEDelisting notice
CMPSCOMPASS PathwaysReleaseCompass Pathways to Participate in 2026 Cantor Global Healthcare Conference on September 9, 2026
CABACabaletta BioReleaseCabaletta Bio to Participate in Upcoming Investor Conferences
BLTEBelite BioReleaseBelite Bio to Participate in Four Upcoming Investor Conferences
BEAMBeam TherapeuticsReleaseBeam Therapeutics Appoints Eric Foster as Chief Commercial OfficerBeam just hired Eric Foster — the exec who helped build Horizon Therapeutics' rare-disease machine into a $2.75B franchise — as CCO, five weeks before ERS and with a year-end BLA on the clock. It's a direct answer to the commercial execution bear case.
BBOTBridgeBio Oncology TherapeuticsS-3Shelf registration → BD updateBBOT quietly filed a $500M shelf and activated a $200M ATM facility on the same day it registered 63M legacy shares for resale — materially changing the dilution picture heading into the 2H 2026 data catalysts.
BBOTBridgeBio Oncology TherapeuticsReleaseBBOT to Participate in Upcoming Investor Healthcare Conferences → BD updateSummary on the S-3
BBOTBridgeBio Oncology TherapeuticsPOS AMPost-effective amendment → BD updateSummary on the S-3
ATHEAlterity Therapeutics6-KForeign issuer report · EX-99.1 EXHIBIT 99.1
ARDXArdelyxReleaseArdelyx to Participate in Upcoming Investor Conferences
ANABAnaptysBioReleaseAnaptys Announces Participation at the H.C. Wainwright 28th Annual Global Investment Conference
AKBAAkebia TherapeuticsReleaseAkebia Therapeutics to Conduct Investor Meetings at the 2026 Wells Fargo Healthcare Conference in Boston
ACETAdicet BioReleaseAdicet Bio Announces Completion of Last Patient Visit for Planned Analysis of prula-cel (formerly ADI-001) Study in Patients with Systemic Lupus Erythematosus With or Without Lupus Nephritis and Provi → BD updateSummary on the 8-KBD extracted 1 program update from this document → ACET pipeline
ACETAdicet Bio8-KCurrent report: Reg FD disclosure · EX-99.1 → BD updateAdicet has completed the last patient visit for its 22-patient prula-cel analysis — topline data and pivotal trial design details are now expected this month, compressing the binary from "eight weeks away" to imminent.