Gilead Sciences' Livdelzi Meets Primary Endpoint in Phase 3 Biliary Cholangitis Trial

Gilead Sciences announced on June 2, 2026, that its investigational drug Livdelzi (seladelpar) achieved the primary endpoint in a pivotal Phase 3 study for primary biliary cholangitis (PBC). The trial demonstrated statistically significant and clinically meaningful improvements in liver biomarkers, including alkaline phosphatase normalization, compared to placebo. The positive outcome bolsters Gilead's rare disease portfolio and supports a U.S. regulatory filing expected in the second half of 2026. Livdelzi, an oral PPAR delta agonist, was acquired through Gilead's $4.3 billion purchase of CymaBay Therapeutics in 2024. PBC affects roughly 130,000 Americans, with a high unmet need for newer therapies. Gilead shares gained 2.5% in pre-market trading following the news. If approved, Livdelzi would compete with existing treatments like Intercept Pharmaceuticals' Ocaliva. Detailed study results will be presented at an upcoming medical meeting.