FDA priority review for Agios mitapivat

The U.S. United States — Food and Drug Administration granted priority review to Agios Pharmaceuticals' supplemental new drug application for mitapivat to treat sickle cell disease. The FDA set a PDUFA goal date of November 1, 2026. If approved, mitapivat would become the first oral pyruvate kinase activator for sickle cell disease. The application is supported by data from Phase 2 and Phase 3 RISE UP trials. Mitapivat is already approved in the U.S. for pyruvate kinase deficiency and thalassemia. Agios shares rose over 12% on the news. Royal Bank of Canada — RBC Capital Markets raised its price target on Agios to $32, and Bank of America reiterated its buy rating. Agios also entered a license agreement with Oscotec for a SYK inhibitor and reported strong Q1 2026 earnings with net revenues up 138% year over year.