First Oral Pyruvate Kinase Activator Approaches Approval

Summary Agios Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease (SCD) and granted Priority Review, establishing a PDUFA target action date of November 1, 2026. If approved, mitapivat would…