Cogent Biosciences, Inc. COGT
Cogent Biosciences, Inc. (Nasdaq: COGT) is an oncology drug developer. Its lead program, Bezuclastinib (CGT9486), is in Phase 3 for Systemic mastocytosis (NonAdvSM, AdvSM) and GIST (with sunitinib). Its next catalyst on record is KRAS inhibitor: IND submission (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: KRAS inhibitor — IND submission (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Bezuclastinib | Non-advanced systemic mastocytosis (SUMMIT Phase 2 positive; NDA accepted March 2026) | small molecule | Phase 3 |
| Bezuclastinib + sunitinib | Second-line GIST (PEAK Phase 3 positive; NDA accepted with Priority Review May 2026) | small molecule | Phase 3 |
| Bezuclastinib | Advanced systemic mastocytosis (APEX Phase 2 positive; NDA submitted June 2026) | small molecule | Phase 3 |
| Bezuclastinib + sunitinib | First-line GIST with exon 9 mutations (Phase 2 initiated Q2 2026) | small molecule | Phase 2 |
| CGT4255 | Mutant ErbB2 solid tumors incl. CNS involvement (Phase 1 dose escalation) | small molecule | Phase 1 |
| CGT6297 | PI3Kalpha-mutant solid tumors (Phase 1 dose escalation) | small molecule | Phase 1 |
| CGT4859 | FGFR2/3-driven cancers (Phase 1; named in 10-K, not highlighted in 10-Q) | small molecule | Phase 1 |
| KRAS inhibitor | KRAS-mutant cancers (research) | small molecule | Pre-clinical |
| JAK2 V617F inhibitor | Myeloproliferative neoplasms (research) | small molecule | Pre-clinical |
Recent results and decisions
- Aug 10, 2026accepted FDA accepted GIST NDA with priority review; PDUFA date November 30, 2026.
Announced FDA acceptance of the New Drug Application (NDA) with priority review for bezuclastinib in combination with sunitinib in patients with GIST who have received prior treatment with imatinib.
Filing - Aug 10, 2026started Single-arm 40-patient extension cohort of PEAK initiated in first-line KIT exon 9 GIST.
Announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of the bezuclastinib combination in first-line GIST patients with KIT exon 9 primary mutations who have received limited or no imatinib treatment.
Filing - Aug 10, 2026completed enrollment Enrollment completed in SUMMIT avapritinib-switch extension; preliminary results expected by end of 2026.
Announced completion of enrollment in the “avapritinib switch” SUMMIT extension trial with preliminary results expected by end of 2026.
Filing
7 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.