Agios Pharmaceuticals Says FDA Has Not Issued Decision On Agios' sNDA for Mitapivat

Reuters
2025.12.08 12:28
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Dec 8 (Reuters) - Agios Pharmaceuticals Inc:AGIOS PROVIDES UPDATE ON U.S. SNDA FOR MITAPIVAT IN THALASSEMIAAGIOS PHARMACEUTICALS INC - FDA HAS NOT ISSUED DECISION ON AGIOS’ SNDA FOR MITAPIVATAGIOS PHARMACEUTICALS INC - COLLABORATING WITH FDA ON LABELING AND REMS MATERIALS FOR FOR MITAPIVATAGIOS PHARMACEUTICALS INC - FDA HAS NOT REQUESTED NEW EFFICACY OR SAFETY DATAAGIOS PHARMACEUTICALS INC - FDA HAS NOT PROVIDED TIMELINE FOR REGULATORY DECISION Source text: Further company coverage: