Ipsen Says Phase 3 Trial of Bylvay in Biliary Atresia Misses Primary Endpoint

01:47 AM EDT, 07/24/2026 (MT Newswires) -- Ipsen (IPN.PA) said Friday the phase 3 Bold trial of Bylvay, or odevixibat, in patients with biliary atresia did not meet its primary endpoint of improvement in native liver survival. The study assessed Bylvay against placebo, particularly in patients who already underwent Kasai hepatoportoenterostomy. The French biopharmaceutical company said the safety profile of the drug was in line with established information. Ipsen is also conducting an open-label extension of the study to assess the longer-term safety and efficacy of the drug in patients who have already undergone the Bold trial. The company expects to decide on the continuation of the open-label extension after a comprehensive analysis of trial data.