Agios Pharmaceuticals Submits Supplemental New Drug Application To FDA Seeking Accelerated Approval Of Oral Pyruvate Kinase Activator Mitapivat; To Also Present New Data On Mitapivat At 31st European Hematology Association Congress

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced the submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the U.S. accelerated approval of mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease. The submission follows agreement with the FDA on the confirmatory clinical trial, which is required under the accelerated approval pathway.

Additionally, Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that new data on mitapivat, an oral pyruvate kinase (PK) activator, will be featured in oral and poster presentations during the 31st European Hematology Association (EHA) Congress (EHA 2026) in Stockholm, Sweden, June 11-14, 2026.