AGIO PDUFA Date: Mitapivat Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Nov 1, 2026 · Agios Pharmaceuticals · Sickle cell disease (sNDA)
Key facts FDA PDUFA target date 2026-11-01
Drug / candidate Mitapivat
Indication Sickle cell disease (sNDA)
Company Agios Pharmaceuticals
Market-cap tier Mid
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All November 2026 PDUFA dates → FAQ When is the AGIO PDUFA date? The FDA PDUFA target date for AGIO (Agios Pharmaceuticals) is 2026-11-01 for Mitapivat. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is AGIO's drug Mitapivat? Mitapivat is Agios Pharmaceuticals's candidate under FDA review for Sickle cell disease (sNDA).
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