Upcoming FDA decision · November 1, 2026
Mitapivat PDUFA date: FDA decision expected November 1, 2026
16 days to goAgios Pharmaceuticals, Inc. (AGIO) →
The FDA is expected to decide on Mitapivat from Agios Pharmaceuticals, Inc. in Sickle cell disease by the PDUFA target action date of November 1, 2026. For Sickle cell disease. sNDA, accelerated approval, Priority Review. 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: biospace.com · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 1
Target action date
NDA
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Mitapivat?
- The FDA's PDUFA target action date for Mitapivat is November 1, 2026. The FDA can act before that date, and the review can be extended.
- What is Mitapivat being reviewed for?
- The application under FDA review covers Sickle cell disease.
- Which company is developing Mitapivat?
- Agios Pharmaceuticals, Inc. (AGIO).
- 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).