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Leerink notes that Agios Pharmaceuticals announced the FDA granted Priority Review for the sNDA for mitapivat in sickle cell disease with a PDUFA date of 11/1/26 suggesting imminent approval. The Phase 3 REIGNITE trial is the confirmatory study required under the accelerated approval pathway and the agency requires tha
Agios Pharmaceuticals announced that the FDA has accepted its supplemental new drug application for mitapivat, an oral pyruvate kinase activator, in sickle cell disease with a priority review. The Prescription Drug User Fee Act goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is November