Agios Pharmaceuticals, Inc. (AGIO) shares climbed 19.97%, closing at $29.50, up $4.91, after the U.S. Food and Drug Administration approved AQVESME (mitapivat) as an oral treatment for anemia in adults with both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.
In the session, AGIO opened near $24.85, reached an intraday high of around $30.10, and saw a low of nearly $24.70, compared to its previous close of $24.59. AGIO trades on the NasdaqGS.
The approval makes AQVESME the only FDA-authorized medicine for anemia associated with these forms of thalassemia, based on Phase 3 trial results showing significant improvement in hemoglobin and quality-of-life measures compared with placebo. The drug will be available following implementation of a Risk Evaluation and Mitigation Strategy program required by the FDA due to liver-injury risks observed in a small number of patients.
Trading volume was reflecting strong investor interest in the expanded indication, which could broaden Agios' revenue base and market opportunity in rare blood disorders.
AGIO's 52-week range recently spanned from the low of the $20s toward the upper $20s, with shares moving sharply higher after the news.
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