Cogent Biosciences, Inc.
PDUFA Confirmed
bezuclastinib
NonAdvanced Systemic Mastocytosis
Countdown
176days
FDA decision · Dec 30, 2026
What's at stake The FDA's approval decision on bezuclastinib for NonAdvanced Systemic Mastocytosis is due Dec 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“Acceptance of the NDA for bezuclastinib in NonAdvSM in February 2026”

Provenance

2 sources on file.

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