Agios Pharmaceuticals Says FDA Extends Mitapivat PDUFA Date For Sickle Cell Disease To February 1, 2027

• FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease
• FDA classified Agios’ response to the information request as a major amendment to the mitapivat sNDA, resulting in a three-month review extension
• Mitapivat sNDA was submitted under the FDA’s accelerated approval pathway and granted Priority Review, with an original PDUFA goal date of November 1, 2026
• Agios will continue its labeling discussions with the FDA as part of the ongoing sNDA review, including elements of a potential REMS

CAMBRIDGE, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease. The PDUFA goal date for this sNDA, which was submitted under the FDA’s accelerated approval pathway and granted Priority Review, is now February 1, 2027.