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GlobeNewswire·

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

FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell diseaseFDA classified Agios’ response to the information request as a major amendment to the mitapivat