Agios' Mitapivat for Sickle Cell Disease Granted FDA Priority Review

Agios Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease with a Priority Review designation. The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA's accelerated approval pathway, is set for November 1, 2026.