Bezuclastinib in combination with sunitinib PDUFA date: FDA decision expected November 30, 2026
The FDA is expected to decide on Bezuclastinib in combination with sunitinib from Cogent Biosciences, Inc. in GIST previously treated with imatinib (with sunitinib) by the PDUFA target action date of November 30, 2026. For GIST previously treated with imatinib (with sunitinib). NDA, Priority Review, Breakthrough Therapy. Verified against the company announcement on 2026-10-16.
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: investors.cogentbio.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
Questions about this FDA decision
- When is the PDUFA date for Bezuclastinib in combination with sunitinib?
- The FDA's PDUFA target action date for Bezuclastinib in combination with sunitinib is November 30, 2026. The FDA can act before that date, and the review can be extended.
- What is Bezuclastinib in combination with sunitinib being reviewed for?
- The application under FDA review covers GIST previously treated with imatinib (with sunitinib).
- Which company is developing Bezuclastinib in combination with sunitinib?
- 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).