As of Oct 26, 2026: Agios Pharmaceuticals (AGIO) has a PDUFA date for mitapivat on Nov 1, 2026, in 6 days. Its Quality Score is 10. Scores as of 8:36 PM ET, 15 minutes behind.

AGIO FDA decision on Mitapivat

Agios Pharmaceuticals · PDUFA date

PDUFA dateNov 1in 6 days Quality Score10Average

Cash runway10quarters of cash

What the company said

“sNDA for mitapivat granted FDA Priority Review in sickle cell disease with PDUFA goal date of November 1, 2026”

PDUFA date, Nov 1, 2026. As Agios Pharmaceuticals stated in its 8-K of Jul 30, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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