2024-01-03 07:01:21 ET
Agios Pharmaceuticals ( NASDAQ: AGIO ) shares rose ~33% premarket on Wednesday after a global late-stage trial of mitapivat in adults with non-transfusion-dependent alpha- or beta-thalassemia achieved its primary endpoint of hemoglobin response.
Results from the Phase 3 ENERGIZE study showed that 42.3% of patients in the mitapivat dosing regime achieved a hemoglobin response, compared to 1.6% of patients in the placebo arm (2-sided p<0.0001).
Treatment with mitapivat also demonstrated statistically significant improvements compared to placebo for both key secondary endpoints. Overall, during the 24-week double-blind period, incidence of adverse events was similar across mitapivat and placebo arms.
Agios ( AGIO ) is advancing the fully enrolled Phase 3 ENERGIZE-T study of mitapivat in adults with transfusion-dependent alpha- or beta-thalassemia and expects to announce data from this 48-week study in mid-2024.
It intends to file for regulatory approval of mitapivat as a treatment for thalassemia by the end of 2024, incorporating all available data from both studies.
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Agios stock rallies after mitapivat meets key goal in thalassemia trial