Cogent Biosciences, Inc. COGT
Cogent Biosciences, Inc. (Nasdaq: COGT) is a hematology drug developer. Its lead program, bezuclastinib (CGT9486), is in Phase 3 for Non-Advanced Systemic Mastocytosis (NonAdvSM). Its next catalyst on record is Bezuclastinib + sunitinib (GIST): PDUFA target action date (November 30, 2026).
Upcoming catalysts
- November 30, 2026Bezuclastinib + sunitinib (GIST) — PDUFA target action date
Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026
- November 30, 2026bezuclastinib (GIST) — PDUFA action date
Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026
- December 30, 2026Bezuclastinib (NonAdvSM) — PDUFA target action date
Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026
- June 2027bezuclastinib (AdvSM) — PDUFA action date
The FDA assigned a PDUFA target action date of June 29, 2027.
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 (NonAdvSM) | small molecule | Phase 3 |
| bezuclastinib | Advanced Systemic Mastocytosis (AdvSM) | small molecule | Phase 3 |
| bezuclastinib + sunitinib | Gastrointestinal Stromal Tumors (GIST), second-line | small molecule | Phase 3 |
| bezuclastinib + sunitinib | GIST, first-line (extension cohort) | small molecule | Phase 2 |
| CGT4255 | ErbB2 mutant solid tumors (CNS metastases) | small molecule | Phase 1 |
| CGT6297 | PI3Kα mutant cancers | small molecule | Phase 1 |
| KRAS inhibitor | KRAS mutant cancers | small molecule | Pre-clinical |
| JAK2 V617F inhibitor | Myeloproliferative neoplasms | small molecule | Pre-clinical |
Recent results and decisions
- Nov 5, 2026accepted FDA accepted NDA for bezuclastinib in Advanced Systemic Mastocytosis with PDUFA date of June 29, 2027.
Announced the U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM).
Filing - Nov 5, 2026started Initiated 40-patient extension cohort of PEAK trial investigating bezuclastinib plus sunitinib in first-line GIST.
Announced the initiation of a single-arm, 40 patient extension cohort of the PEAK trial investigating the safety and efficacy of bezuclastinib in combination with sunitinib in first-line GIST patients.
Filing - 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
9 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 hematology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.