Agios Pharmaceuticals' PDUFA Goal Date for Sickle Cell Disease Treatment Mitapivat Extended by FDA; Shares Fall Pre-Bell

08:01 AM EDT, 10/30/2026 (MT Newswires) -- Agios Pharmaceuticals (AGIO) said Friday that the US Food and Drug Administration has extended the Prescription Drug User Fee Act goal date for the supplemental New Drug Application for mitapivat to treat sickle cell disease patients. The company said the date has been extended to Feb. 1. On Oct. 9, the company said the FDA requested additional information to evaluate whether a Risk Evaluation and Mitigation Strategy was necessary for mitapivat in sickle cell disease. Agios submitted its response Oct. 19, which it said included approximately nine months of updated safety data. The company said the FDA told it on Wednesday that its response had been classified as a major amendment to the application, which resulted in a three-month review extension. Shares of Agios Pharmaceuticals were down 7.3% pre-bell.