FDA Extends PDUFA Date For Agios Pharmaceuticals' PYRUKYND By 3 Months

(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO), Thursday announced the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act goal date for the supplemental New Drug Application of PYRUKYND by three months from September 7, 2025, to December 7, 2025.

PYRUKYND is an oral pyruvate kinase activator for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, a rare, inherited blood disease.

The announcement comes as the company submitted a proposed Risk Evaluation and Mitigation Strategy to FDA, which is a major amendment to the original PYRUKYND sNDA, resulting in a three-month review extension.

CEO Brian Goff commented, "We look forward to continuing our collaborative engagement with the FDA, with the goal of bringing this disease-modifying oral medicine to adult patients with thalassemia in the U.S."

In the pre-market hours, AGIO is trading at $33.85, down 16.65 percent on the Nasdaq.