<h1>PPAR alpha/gamma agonist meets 52-week composite endpoint and ALP normalization in Phase 2b/3 PBC trial; U.S. filing planned Q1 2026</h1> A sponsor reported positive topline results from a pivotal Phase 2b/3 randomized, double-blind, placebo-controlled trial of an investigational PPAR alpha/gamma agonist for adults with primary biliary cholangitis who were nonresponsive or intolerant to ursodeoxycholic acid. The trial met its primary composite biochemical endpoint at 52 weeks and a key secondary endpoint of alkaline phosphatase normalization, with a treatment difference favoring active therapy and statistical significance. Adverse events were generally balanced versus placebo. The sponsor intends to file a U.S. regulatory application in Q1 2026 and plans to present full data at a future scientific congress.