Agios Shares Tumble as FDA Pushes Back Key Drug Decision

Investors in Agios Pharmaceuticals faced a sharp selloff after US regulators announced a three-month delay for the approval decision of the company’s thalassemia treatment, PYRUKYND. The anticipated September verdict has now been pushed to December 7, 2025, sending the biotech firm’s stock plummeting.

The US Food and Drug Administration (FDA) extended its review timeline after classifying a recently submitted Risk Evaluation and Mitigation Strategy (REMS) from Agios as a “major amendment.” This classification triggers an automatic extension of the review period under standard regulatory procedures. Company officials clarified that the delay does not stem from newly identified safety issues or concerns about the drug’s efficacy.

Market response was swift and severe. Agios shares collapsed by 20 percent, driving the... Read more...