Ipsen says Phase III BOLD trial of Bylvay in biliary atresia misses primary endpoint

Reuters2026/07/24 07:14

By:Reuters

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Ipsen reported its Phase III BOLD trial of Bylvay (odevixibat) in biliary atresia failed its primary endpoint on native liver survival vs placebo.
Topline results showed no new safety signals, consistent with odevixibat’s established safety profile in approved indications.
The randomized, double-blind study enrolled 254 patients in 19 countries, dosing odevixibat 120 mcg/kg/day for up to 104 weeks.
Ipsen will review full data before deciding whether patients continue in the ongoing open-label extension study, BOLD-EXT.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ipsen SA published the original content used to generate this news brief on July 24, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Ipsen says Phase III BOLD trial of Bylvay in biliary atresia misses primary endpoint

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