Why Did Agios Plunge 26.94%? FDA Delays PYRUKYND Review

On September 4, 2025, Agios experienced a significant drop of 26.94% in pre-market trading, marking a notable decline in its stock performance.

Agios Pharmaceuticals Inc. recently announced that the U.S. FDA has extended the PDUFA goal date for the supplemental New Drug Application (sNDA) of PYRUKYND, an oral pyruvate kinase activator, by three months to December 7, 2025. This extension was due to the need for additional information to support the application, which aims to expand the drug's label to include treatment for adult patients with all forms of alpha- and beta-thalassemia, regardless of transfusion requirements.

This delay has raised concerns among investors, as the FDA's decision on September 7, 2025, was a critical catalyst for the company. The delay in the review period has led to a drop in Agios' stock price, reflecting investor uncertainty about the drug's regulatory approval prospects.

PYRUKYND is currently approved for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency, a rare disease. The drug has shown consistent revenue growth since its launch in 2022, with year-over-year increases in revenue. However, the delay in the FDA's review process has cast a shadow over the company's future prospects, as investors await further updates on the drug's regulatory status.