Agios Announces the Randomized Phase 3 ClarIDHy Trial of TIBSOVO® (ivosidenib) Achieved its Primary Endpoint in Previously Treated IDH1 Mutant Cholangiocarcinoma Patients
Agios Pharmaceuticals, Inc. (AGIO)
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am
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Source: GlobeNewswire
– TIBSOVO® Demonstrated a Statistically Significant Improvement in Progression-Free Survival Compared to Placebo – – Safety Profile Consistent with Published Phase 1 Data in Patients with IDH1 Mutant Solid Tumors – – Supplemental New Drug Application on Track for Submission by End of 2019 – CAMBRIDGE, Mass., May 15, 2019 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the global Phase 3 ClarIDHy trial of TIBSOVO® (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint. Treatment with TIBSOVO® demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. The safety profile observed in the study was consistent with previously published data. A full analysis of the ClarIDHy tri
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