Gilead Sciences Reports Phase 3 RESPONSE Results for Seladelpar in Primary Biliary Cholangitis

Gilead Sciences today announced results from the Phase 3 RESPONSE trial evaluating seladelpar in patients with primary biliary cholangitis (PBC) who had an inadequate response to ursodeoxycholic acid. The trial met its primary endpoint, demonstrating a significant reduction in alkaline phosphatase levels and improvements in pruritus compared to placebo at week 52. These results led to FDA approval of seladelpar for PBC.