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Add as a preferred source on GoogleFDA Extends Agios’ Mitapivat Review for Sickle Cell Disease by Three Months
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.
Riza Dagoc
Riza Dagoc reports on regulation, investing and the digital-asset business for TokenPost. Send corrections or tips to info@tokenpost.com.