(RTTNews) - Agios Pharmaceuticals (AGIO) announced that the FDA has not yet issued a regulatory decision on the supplemental New Drug Application for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The company noted that the sNDA remains under active review. The PDUFA goal date issued by the FDA was December 7, 2025.
Agios said the FDA has not provided a timeline for its regulatory decision. The company continues to work with the FDA to conclude the review of the sNDA.
Shares of Agios Pharmaceuticals are down 2.6% to $27.00 in pre-market trade on Monday.
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