08:06 AM EDT, 09/04/2025 (MT Newswires) -- Agios Pharmaceuticals ( AGIO ) said Thursday the US Food and Drug Administration has extended the target date to approve the company's supplemental new drug application of Pyrukynd for treating adults with thalassemia by three months to Dec. 7.

The agency requested a proposed risk evaluation and mitigation strategy to address potential liver injury, which Agios submitted as a major amendment, the company said.

The extension was not due to new efficacy or safety data, Agios said.

The company also said the filing is backed by results from its global phase 3 Energize and Energize-T trials in non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

Shares of the company were down by more than 18% in recent Thursday premarket activity.