Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
FDA decision (PDUFA) target Nov 30, 2026 · Cogent Biosciences · Gastrointestinal stromal tumors (GIST), 2L+
Also under FDA review from Cogent Biosciences, as a separate application: Bezuclastinib (SUMMIT), Dec 30, 2026. One application, one page; this page is the PEAK application with the Nov 30, 2026 goal date.
Per Cogent's August 10, 2026 8-K, the PDUFA date for bezuclastinib in GIST (the PEAK application) is November 30, 2026, and the PDUFA date for bezuclastinib in nonadvanced systemic mastocytosis (SUMMIT) is December 30, 2026. (Cogent Biosciences 8-K, August 10, 2026)
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+.