Agios says FDA grants priority review for mitapivat sickle cell disease filing

Agios Pharmaceuticals, Inc.

Agios Pharmaceuticals, Inc.

AGIO

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  • Agios won FDA Priority Review for its mitapivat sNDA in sickle cell disease under the accelerated approval pathway.
  • PDUFA goal date set for Nov. 1, 2026.
  • Approval would position mitapivat as the first oral pyruvate kinase activator for sickle cell disease.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Agios Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607070700PRIMZONEFULLFEED9757762) on July 07, 2026, and is solely responsible for the information contained therein.

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