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Cogent Biosciences

COGT Rare disease Lead: NDA Submitted ★ Read the deep dive → 7 Biotech Distilled articles ↓ 23 filings & releases ↓ Cash $217M (Sep 30, 2026) ↓ 7 verdicts ↓ 5 timing quotes ↓
HematologyOncology Small Molecule

Market cap $5.51B 174.0M shares (10-Q, Nov 3, 2026) × $31.64 close Nov 6, 2026

Most recent annual filing: 2026-02-15

Catalyst timeline

7 trackedQuarter catalyst calendar →
  1. Bezuclastinib commercial launch2H 2026Bezuclastinib commercial launch, 2H 2026, routine
  2. CGT1815 pan-KRAS Inhibitor IND filing4Q 2026CGT1815 pan-KRAS Inhibitor IND filing, 4Q 2026, notable
  3. CGT1145 IND filing4Q 2026CGT1145 IND filing, 4Q 2026, notable
  4. Bezuclastinib + sunitinib GIST PDUFANov 30, 2026Bezuclastinib + sunitinib GIST PDUFA, Nov 30, 2026, thesis-defining
  5. Bezuclastinib NonAdvSM PDUFA dateDec 30, 2026Bezuclastinib NonAdvSM PDUFA date, Dec 30, 2026, thesis-defining
  6. 1L exon 9 GIST extension20271L exon 9 GIST extension, 2027, notable
  7. Bezuclastinib AdvSM PDUFA dateJun 29, 2027Bezuclastinib AdvSM PDUFA date, Jun 29, 2027, thesis-defining

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 (7 active programs)

Discontinued (1)

Capital (as filed)

Cash
$217M cash and cash equivalents · Sep 30, 2026 (10-Q)
Short-term investments
$574M Sep 30, 2026
Operating cash flow
−$80.8M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$791M cash, runway late 2028 per the update of Nov 5, 2026 — the company's own words as read there, not the filed figure

Offering documents (1)

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 (7)

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

Verdict history (7 calls)

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

  1. 2026-04-18 Buy core Cogent Biosciences (COGT) - Scientific Deep Dive for Bezuclastinib and Pipeline Products Bezuclastinib offers best-in-class Type 1 KIT selectivity with a CNS-sparing safety profile, three massive regulatory catalysts in 2026, and a $900M fortress balance sheet eliminating dilution risk ahead of a combined $8B TAM commercial launch.
  2. 2026-05-28 Buy core UPDATE: Cogent Biosciences (COGT) - The GIST Clock is Set, ASCO is Saturday Priority Review acceptance with November 30 GIST PDUFA, no AdCom, and no review issues identified front-loads the launch sequence and shrinks regulatory tail risk ahead of the ASCO full PEAK dataset.
  3. 2026-06-02 Buy core UPDATE: Cogent Biosciences (COGT) - PEAK Goes Under the Microscope, and a 1L Shot Opens Up ASCO full PEAK dataset confirmed topline with a PFS2 durability signal (HR=0.57, median not reached) and a new 1L exon 9 cohort adds free optionality, reinforcing the M&A appeal and the accumulation case.
  4. 2026-06-12 Buy core UPDATE: Cogent Biosciences (COGT) - APEX Goes Deep, and the Third Pivotal Lands Clean APEX ORR upgraded to 65% mIWG with 91% VAF reduction and ~33% undetectable in AdvSM, AdvSM NDA submission imminent, and all three pivotal datasets now holding up under scrutiny with the bear case unchanged.
  5. 2026-08-11 Buy core UPDATE: Cogent Biosciences (COGT) - The Fortress Gets a Tap, and the Field Team Lands Full commercial organization is hired, three NDAs pending with two dated PDUFAs, and pro forma cash of $865.9M covers both launches, though the $400M ATM introduces real dilution and the easy part of the move may be behind us.
  6. 2026-09-02 Buy core UPDATE: Cogent Biosciences (COGT) - The Silent Killer Gets a Contract A five-year commercial supply agreement with Hovione directly addresses the single-source API bear case, and a 16.8% pullback on no fundamental news restores asymmetry into the November 30 Priority-Reviewed PDUFA.
  7. 2026-09-16 Buy core UPDATE: Cogent Biosciences (COGT) - The Third Clock Is Set FDA accepted the AdvSM NDA with a June 29, 2027 PDUFA and identical 'no AdCom, no review issues' language, completing the regulatory triple-play; down 21% from August on process wins with no fundamental deterioration widens asymmetry into the first PDUFA.

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 (5 quotes from 4 filings)

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 (23)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 5, 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 →

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