Agios Pharmaceuticals Inc., AGIO, FDA Calendar, PDUFA Date

Company Name	Agios Pharmaceuticals, Inc. AGIO
Drug Name	Pyrukynd (sNDA)
Event Name	FDA decision on Pyrukynd for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
Event Date	12/07/2025
Outcome Date
Outcome	Pending
Drug Status	On Sep. 4, 2025, the FDA extended the decision date by three months from September 7, 2025, to December 7, 2025
Rival Drugs
Market Potential
Other Approvals	Pyrukynd received FDA approval for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency in February 2022
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