Mitapivat is a Agios Pharmaceuticals program in Sickle cell disease (sNDA). Its PDUFA date is Nov 1, 2026, the FDA's goal date to complete review of the application. 1 FDA decision on record below. Every date links its source.
Mitapivat is marketed as AQVESME (mitapivat); the events below include those tracked under the brand name. Indication under review: Sickle cell disease (sNDA). Sponsor: Agios Pharmaceuticals (AGIO). Market-cap tier at the time we tracked it: Mid. We track 4 catalyst events for this program: 2 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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