Agios Pharmaceuticals Slumps as FDA Delays Mitapivat Decision

The company’s stock plunged 19% to $30.26 following the announcement, stripping away some of the gains seen earlier this year. The regulatory setback stems from an October request for additional data regarding potential risk mitigation strategies. In response, Agios provided nine months of updated safety information from ongoing trials to address agency concerns.

Despite the delay, leadership at Agios maintains that the drug’s benefit-risk profile remains stable. The company reported no instances of severe hepatocellular injury in its sickle cell disease trials that would mirror adverse outcomes seen in other studies. Ongoing discussions with the FDA will now focus on final labeling requirements as both parties navigate the extended review period.