MODERATE IMPACT - Servier has resubmitted an MAA to the EMA for its IDH1 inhibitor Tibsovo (ivosidenib) for use with azacitidine as a first-line treatment for patients with IDH1-mutated AML who are not eligible for intensive chemotherapy, and…
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HIGH IMPACT - At its 4Q/full-year 2021 earnings release, Voyager announced a license agreement with Novartis for the TRACER AAV capsids. Under the agreement, Novartis may exercise options to license novel AAV capsids generated from Voyager’s…
HIGH IMPACT - Madrigal reported positive topline data from the double-blind portion of the its phase 3 MAESTRO-NAFLD study of resmetirom in NASH. Patients in the study were identified based on non-invasive imaging and biomarkers, and were treated…
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HIGH IMPACT - During Roche’s HDSA presentation, the company discussed GENERATION-HD1 trial data and post-hoc analysis in subgroups of patients. The call was led by Peter McColgan (Roche) and Lauren Boak (Roche). The speaker mentioned that…
HIGH IMPACT - Poseida announced in its Q3 press release that it will end its P-BCMA-101 autologous CAR-T program and prioritize its allogeneic CAR-T P-BCMA-ALLO1. “While we believe the P-BCMA-101 autologous program has competitive advantages…
HIGH IMPACT - Reata has submitted an NDA to the FDA for bardoxolone methyl for the treatment of chronic kidney disease caused by Alport Syndrome. Reata has requested priority review for the application. The submission was based on the results…
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