As of Oct 26, 2026: Cogent Biosciences (COGT) has a PDUFA date for bezuclastinib on Nov 30, 2026, in 35 days. Its Quality Score is 0. Scores as of 8:36 PM ET, 15 minutes behind.

Cogent Biosciences (COGT) logo

COGT FDA decision on Bezuclastinib

Cogent Biosciences · PDUFA date

What the company said

“Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026”

PDUFA date, Nov 30, 2026. As Cogent Biosciences stated in its 8-K of Aug 10, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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The company set the date; the FDA can act before it or extend it. The score is delayed at least 15 minutes.

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