AGIO's Filing for Mitapivat in SCD Gets FDA's Priority Tag, Stock Up

Agios shares jumped after the FDA accepted and granted priority review to its supplemental NDA (sNDA) for mitapivat in sickle cell disease. A regulatory decision is expected by Nov. 1, 2026, supporting a near-to-medium-term positive catalyst for the program.

Analysis

Agios shares jumped after the FDA accepted and granted priority review to its supplemental NDA (sNDA) for mitapivat in sickle cell disease. A regulatory decision is expected by Nov. 1, 2026, supporting a near-to-medium-term positive catalyst for the program.