Agios Announces New PDUFA Goal Date of February 1, 2027, for Mitapivat Sickle Cell Disease sNDA; Company Is Launch-Ready and in Labeling Discussions with FDA

Markets GlobeNewswire By GlobeNewswire 30 Oct 2026 11:00 1 min read
Agios Announces New PDUFA Goal Date of February 1, 2027, for Mitapivat Sickle Cell Disease sNDA; Company Is Launch-Ready and in Labeling Discussions with FDA

Agios announces that the FDA has extended the PDUFA goal date for the sNDA for mitapivat in sickle cell disease to February 1, 2027.

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