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VisitFDA approval for Mitapivat for Thalassemia by end of 2024?
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FDA official announcements and press releases
Agios' Mitapivat Achieves Positive Phase 3 Results for Thalassemia, 30.4% Response, Stock Up 20%
Jun 3, 2024, 11:24 AM
Agios Pharmaceuticals announced on Monday that its drug Mitapivat achieved positive results in a Phase 3 study for treating transfusion-dependent alpha- or beta-thalassemia in adults. The study, named ENERGIZE-T, met its primary endpoint and all key secondary endpoints. The response rate for Mitapivat was 30.4% compared to 12.6% for the placebo, showing significant reduction in the need for blood transfusions. Following the announcement, Agios' stock price surged by 20%, reaching a 2.5-year high.
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FDA approval • 25%
EMA approval • 25%
Both approvals • 25%
No approvals • 25%