COGT PDUFA Date: Bezuclastinib Page updated November 8, 2026 · next FDA decision on the calendar · Data as of Nov 8, 2026 11:32 PM ET FDA decision (PDUFA) target Jun 29, 2027 · Cogent Biosciences · Advanced systemic mastocytosis
Also under FDA review from Cogent Biosciences, as a separate application: Bezuclastinib + sunitinib (PEAK), Nov 30, 2026 ; Bezuclastinib (SUMMIT), Dec 30, 2026 . One application, one page; this page is the application with the Jun 29, 2027 goal date.
Key facts FDA PDUFA target date 2027-06-29
Drug / candidate Bezuclastinib
Indication Advanced systemic mastocytosis
Company Cogent Biosciences
Market-cap tier Mid
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See every 2027 PDUFA date → All June 2027 PDUFA dates → FAQ When is the COGT PDUFA date? The FDA PDUFA target date for COGT (Cogent Biosciences) is 2027-06-29 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 Advanced systemic mastocytosis.
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