7/106 sources · 5 publishersUpdated Oct 30, 18:44 UTC
FDA pushes Agios’ sickle‑cell mitapivat decision to Feb 1 2027
The U.S. FDA extended the PDUFA goal date for Agios Pharmaceuticals’ supplemental NDA for mitapivat in sickle‑cell disease from November 1 2026 to February 1 2027. The agency classified Agios’ response to a request for REMS information as a major amendment, adding a three‑month review extension. Agios submitted about nine months of updated safety data on October 19 2026 and said it remains launch‑ready.
Why it matters
The delay caused Agios’ stock to fall about 18% as investors reassess the timing of the anticipated sickle‑cell launch. The later decision date also pushes back potential revenue from the largest indication for mitapivat.
Key facts
- 1The new FDA PDUFA goal date is February 1 2027. stocktitan.net
- 2The original PDUFA goal date was November 1 2026. stocktitan.net
- 3The review was extended by three months. stocktitan.net
- 4The FDA classified Agios’ response as a major amendment to the sNDA. stocktitan.net
- 5Agios submitted approximately nine months of updated safety data on October 19 2026. finance.yahoo.com
- 6Agios had $964.8 million of cash at the end of June. finance.yahoo.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.