Bezuclastinib is a Cogent Biosciences program in Gastrointestinal stromal tumors (GIST), 2L+. Its PDUFA date is Nov 30, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indications under review: Gastrointestinal stromal tumors (GIST), 2L+; Nonadvanced systemic mastocytosis (NonAdvSM). Sponsor: Cogent Biosciences (COGT). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 2 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Bezuclastinib's next FDA decision or readout?
Bezuclastinib's PDUFA date is Nov 30, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Bezuclastinib's most recent FDA decision?
No FDA decision for Bezuclastinib is in our archive yet.
What is Bezuclastinib used for?
In our records Bezuclastinib is under review or in development for Gastrointestinal stromal tumors (GIST), 2L+; Nonadvanced systemic mastocytosis (NonAdvSM).
Who makes Bezuclastinib?
Cogent Biosciences (COGT).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
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