Agios Pharma slips as FDA extends review of sickle cell drug

By Reuters News

** Agios Pharmaceuticals AGIO.O shares fall 11.2% to $33.06 premarket

** FDA extends review of co's drug mitapivat for sickle cell disease by three months

** Sets new action date of February 1, 2027

** Co says FDA requested additional information to evaluate whether a risk evaluation and mitigation strategy is necessary for the drug for sickle cell

** Sickle cell disease is a rare, inherited blood disorder in which abnormal hemoglobin causes red blood cells to become rigid and sickle-shaped

** Mitapivat is approved under the brand name Pyrukynd for the treatment of a type of hemolytic anemia caused by the deficiency of an enzyme called pyruvate kinase and as Aqvesme for thalassemia

** Up to last close, stock up ~37% YTD

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