Agios Pharmaceuticals Says FDA Extends Mitapivat PDUFA Date For Sickle Cell Disease To February 1, 2027
FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell diseaseFDA classified Agios’ response to the information request as a major amendment to the mitapivat
The FDA asked Agios more questions about their sickle cell medicine. This pushes the approval decision to February 2027, which means the wait got longer.
Last session drawn · prints held ~15 minutes · licensed exchange data
Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.
Disclosure: Educational and informational purposes only. Not financial advice. We educate, not advise. Market data may be delayed up to 15 minutes unless marked real-time. Past performance is not indicative of future results.