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Mineralys Therapeutics

MLYS Lead: NDA Submitted 2 Biotech Distilled articles ↓ 23 filings & releases ↓ Cash $101M (Sep 30, 2026) ↓ 2 verdicts ↓
CardiovascularRenalRespiratory Small Molecule

Market cap $1.36B 88.6M shares (10-Q, Oct 29, 2026) × $15.33 close Nov 6, 2026

Most recent annual filing: 2026-03-12

Catalyst timeline

8 trackedQuarter catalyst calendar →
  1. Mineralys corporate updateNov 2026Mineralys corporate update, Nov 2026, routine
  2. Lorundrostat AHA readoutNov 6–9, 2026Lorundrostat AHA readout, Nov 6–9, 2026, material
  3. Lorundrostat reimbursementNov 30, 2026Lorundrostat reimbursement, Nov 30, 2026, notable
  4. Lorundrostat FDA decisionDec 22, 2026Lorundrostat FDA decision, Dec 22, 2026, thesis-defining
  5. Lorundrostat commercial launch1H 2027Lorundrostat commercial launch, 1H 2027, routine
  6. Lorundrostat Tranche B financingMar 31, 2027Lorundrostat Tranche B financing, Mar 31, 2027, notable
  7. Lorundrostat loan covenant corporate updateSep 30, 2027Lorundrostat loan covenant corporate update, Sep 30, 2027, notable
  8. Lorundrostat loan corporate update2028Lorundrostat loan corporate update, 2028, routine

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (3 active programs)

Capital (as filed)

Cash
$101M cash and cash equivalents · Sep 30, 2026 (10-Q)
Operating cash flow
−$43.1M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$625M cash, runway into 2028 per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (2)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (2 calls)

Every verdict Biotech Distilled has published on Mineralys Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-10-20 Watch Mineralys Therapeutics (MLYS) - Scientific Deep Dive for Lorundrostat and Pipeline Products Lorundrostat will likely be approved but arrives second to AstraZeneca with no randomized advantage, faces a generic payer wall, and needs launch evidence not available until mid-2027 before the investment case is clear.
  2. 2026-11-05 Watch UPDATE: Mineralys Therapeutics (MLYS) - The Patents Come Home, the Specialists Head for the Door Patent ownership is now clean and EV has fallen to ~$1.0B improving the risk/reward, but the specialist base is thinning ahead of the PDUFA and the label, ICER final report, and payer coverage remain unresolved.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Filings & releases (23)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Oct 19, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

2 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)