bezuclastinib PDUFA date: FDA decision expected December 30, 2026
The FDA is expected to decide on bezuclastinib from Cogent Biosciences, Inc. in Advanced Systemic Mastocytosis (AdvSM) by the PDUFA target action date of December 30, 2026. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 26, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for bezuclastinib?
- The FDA's PDUFA target action date for bezuclastinib is December 30, 2026. The FDA can act before that date, and the review can be extended.
- What is bezuclastinib being reviewed for?
- The application under FDA review covers Advanced Systemic Mastocytosis (AdvSM).
- Which company is developing bezuclastinib?
- Cogent Biosciences, Inc. (COGT).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).