11:16 AM EST, 01/08/2025 (MT Newswires) -- Agios Pharmaceuticals ( AGIO ) said Wednesday that the US Food and Drug Administration has accepted for review its supplemental new drug application for Pyrukynd, or mitapivat, for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

The company said the application was based on the results of two phase 2 trials that evaluated mitapivat versus placebo. Agios said the Prescription Drug User Fee Act target date for the application is on Sept. 7.

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