Agios Pharmaceuticals says FDA has not yet issued decision for mitapivat sNDA

Agios Pharmaceuticals (AGIO) announced that the U.S. Food and Drug Administration has not yet issued a regulatory decision on the supplemental New Drug Application for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia and that the sNDA remains under active review. The Prescription Drug User Fee Act goal date issued by the FDA was December 7, 2025. Agios is collaborating closely with the FDA to finalize the labeling documents and Risk Evaluation and Mitigation Strategy materials. The FDA has not requested, and the company has not submitted, any new or additional efficacy or safety data. The FDA has not provided a timeline for its regulatory decision. Agios continues to work expeditiously with the FDA to conclude the review of the sNDA.