NasdaqGS:AGIOBiotechs
How Investors Are Reacting To Agios Pharmaceuticals (AGIO) FDA Delay On Mitapivat Thalassemia Decision
In early December 2025, Agios Pharmaceuticals reported that the FDA missed its December 7 PDUFA goal date and has yet to issue a decision on the supplemental New Drug Application for mitapivat (Pyrukynd) in adult alpha- and beta-thalassemia, although the filing remains under active review and no new efficacy or safety data have been requested.
The delay, which now centers on finalizing labeling and Risk Evaluation and Mitigation Strategy requirements, highlights how regulatory risk...