COGT PDUFA Date: Bezuclastinib Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 30, 2026 · Cogent Biosciences · Gastrointestinal stromal tumors (GIST), 2L+
Key facts FDA PDUFA target date 2026-11-30
Drug / candidate Bezuclastinib
Indication Gastrointestinal stromal tumors (GIST), 2L+
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 the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the COGT PDUFA date? The FDA PDUFA target date for COGT (Cogent Biosciences) is 2026-11-30 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 Gastrointestinal stromal tumors (GIST), 2L+.
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