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COGT PDUFA Date: Bezuclastinib

FDA decision (PDUFA) target Dec 30, 2026 · Cogent Biosciences · Nonadvanced systemic mastocytosis (NonAdvSM)

Also under FDA review from Cogent Biosciences, as a separate application: Bezuclastinib + sunitinib (PEAK), Nov 30, 2026. One application, one page; this page is the SUMMIT application with the Dec 30, 2026 goal date.

Per Cogent's August 10, 2026 8-K, the PDUFA date for bezuclastinib in nonadvanced systemic mastocytosis (the SUMMIT application) is December 30, 2026, and the PDUFA date for bezuclastinib in GIST (PEAK) is November 30, 2026. (Cogent Biosciences 8-K, August 10, 2026)

Key facts

FDA PDUFA target date2026-12-30
Drug / candidateBezuclastinib
IndicationNonadvanced systemic mastocytosis (NonAdvSM)
CompanyCogent Biosciences
Market-cap tierMid

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →All December 2026 PDUFA dates →

FAQ

When is the COGT PDUFA date?
The FDA PDUFA target date for COGT (Cogent Biosciences) is 2026-12-30 for Bezuclastinib. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is COGT's drug Bezuclastinib?
Bezuclastinib is Cogent Biosciences's candidate under FDA review for Nonadvanced systemic mastocytosis (NonAdvSM).