Ipsen provides update on Phase III BOLD trial in biliary atresia
Phase 3negativeBylvayNegative
AI Analysis
Summary
Ipsen announced that its Phase III BOLD trial of Bylvay (odevixibat) failed to meet the primary endpoint of improving native liver survival versus placebo in biliary atresia patients post-Kasai surgery, though the safety profile remained consistent with approved indications.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Not Met
Outcome Details
Phase III BOLD trial did not meet primary endpoint of improvement in native liver survival vs placebo
Importance:8/10
Sentiment:
-0.85
Phase 3 failurePediatric indicationLiver diseaseSafety profile maintained
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Published by GlobeNewswire Pharma on July 24, 2026 5:00 AM