FDA Grants Priority Review To Agios' Mitapivat SNDA In Sickle Cell Disease

Agios Pharmaceuticals said the FDA granted Priority Review to its supplemental NDA for mitapivat for sickle cell disease. Priority Review signals faster regulatory timelines for potential approval, a positive catalyst for AGIO despite no efficacy or financial impact disclosed in the note.

Analysis

Agios Pharmaceuticals said the FDA granted Priority Review to its supplemental NDA for mitapivat for sickle cell disease. Priority Review signals faster regulatory timelines for potential approval, a positive catalyst for AGIO despite no efficacy or financial impact disclosed in the note.