BUZZ - FDA extends review period for sickle cell disease drug, Agios Pharma shares decline

October 30 - ** Agios Pharmaceuticals (AGIO.O) shares fell 11.2% in premarket trading to $33.06

** The U.S. Food and Drug Administration (FDA) has extended the review period for the company's sickle cell disease drug mitapivat (link) by three months

** The new action date is set for February 1, 2027

** The company stated that the FDA requested additional information to assess whether a risk evaluation and mitigation strategy is required for the sickle cell disease drug

** Sickle cell disease is a rare genetic blood disorder characterized by abnormal hemoglobin causing red blood cells to become rigid and shaped like a sickle

** Mitapivat is already approved under the brand name Pyrukynd for the treatment of hemolytic anemia caused by deficiency of an enzyme called pyruvate kinase; it is also marketed as Aqvesme for the treatment of thalassemia (link)

** As of the previous trading day’s close, the stock had risen about 37% so far this year

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