08:50 AM EST, 12/08/2025 (MT Newswires) -- Agios Pharmaceuticals ( AGIO ) said Monday that the US Food and Drug Administration has not yet issued a regulatory decision on the supplemental New Drug Application for mitapivat to treat adults with the blood disorder thalassemia.

The biopharmaceutical company said the sNDA remains under active review, with an FDA-issued Prescription Drug User Fee Act target date of Dec. 7.

Agios also said it is working with the FDA to finalize labeling documents and Risk Evaluation and Mitigation Strategy materials, adding that the regulator hasn't requested any new or additional efficacy or safety data.

Shares of Agios Pharmaceuticals ( AGIO ) were down 2.4% pre-bell.