# FDA Extends Agios’ Mitapivat Review for Sickle Cell Disease by Three Months

By Riza Dagoc

Canonical URL: https://www.tokenpost.com/news/regulation/44812
Published: 2026-10-30T15:16:15.000Z
Updated: 2026-10-30T15:16:15.000Z
Section: Regulation

> The updated PDUFA goal date is Feb. 1, 2027, moved from Nov. 1, 2026. The FDA accepted the application for Priority Review in July.

The Food and Drug Administration extended its review of Agios Pharmaceuticals, Inc.’s supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease by three months, setting a Feb. 1, 2027, goal date.

The revised PDUFA goal date replaces Nov. 1, 2026. The application seeks approval for mitapivat, branded PYRUKYND, for sickle cell disease.

The FDA granted Priority Review to the application in July.