Biotech Distilled
Substack ↗ Subscribe
Subscribe Substack ↗ About

Home › Companies › BLTE

Belite Bio

BLTE Rare disease Lead: NDA Submitted 3 Biotech Distilled articles ↓ 20 filings & releases ↓ Cash $353M (Dec 31, 2025) ↓ 3 verdicts ↓ 1 timing quote ↓
MetabolicOphthalmology Small Molecule

Market cap $6.21B 40.3M shares (vendor count, Nov 7, 2026) × $154.19 close Nov 6, 2026 · share count from the market-data vendor, not the SEC cover page

Most recent annual filing: 2026-03-31

Catalyst timeline

1 trackedQuarter catalyst calendar →
  1. tinlarebant PDUFA dateFeb 12, 2027tinlarebant PDUFA date, Feb 12, 2027, material

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 (6 active programs)

Capital (as filed)

Cash
$353M cash and cash equivalents · Dec 31, 2025 (20-F)
Operating cash flow
−$9.2M annual ÷ 4, year to Dec 31, 2025 (20-F)
As stated in coverage
$773M cash per the update of Sep 8, 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 (3)

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

Verdict history (3 calls)

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

  1. 2026-07-22 Watch Belite Bio (BLTE) — Scientific Deep Dive for Tinlarebant (LBS-008) and Pipeline Products The Stargardt science is de-risked and the balance sheet is a fortress, but at ~$6B near all-time highs the stock already prices in approval plus GA success while the two key questions — vision benefit and PHOENIX readout — remain open.
  2. 2026-08-12 Speculative buy speculative UPDATE: Belite Bio (BLTE) - The Clock Is Set FDA accepted the single-pivotal NDA with Priority Review and a February 12, 2027 PDUFA — the precise de-risking event named as the upgrade trigger — retiring refuse-to-file risk and signaling the agency is prepared to approve on the DDAF imaging endpoint, though the vision-benefit and PHOENIX questions remain open.
  3. 2026-09-09 Speculative buy speculative UPDATE: Belite Bio (BLTE) - A Second Flag on the Board Japan NDA filed under Sakigake widens the STGD1 base case by ~9,500 patients and adds an extended re-examination period, but does not resolve the functional-benefit or PHOENIX questions; the partial-position tranche discipline and upgrade triggers are unchanged.

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.

Timing, in the company's words (1 quote from 1 filing)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (20)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Aug 6, 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 →

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