Leerink sees Priority Review designation as positive sign for Agios' mitapivat
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