https://www.taxtmi.com/news?id=54065 Saroglitazar 1 mg met the EPICS-III trial's composite primary endpoint-clinically meaningful biochemical response based on alkaline phosphatase reductions and bilirubin limits-and a key secondary endpoint of complete ALP normalization at 52 weeks versus placebo. The randomized, double-blind, placebo-controlled Phase 2b/3 trial found saroglitazar generally well tolerated with adverse events balanced between arms. The sponsor plans a U.S. regulatory submission following these topline results, and saroglitazar holds Orphan Drug and Fast Track designations for PBC. en-us Sat, 30 Aug 2025 12:01:04 +0530 Sat, 30 Aug 2025 12:01:04 +0530 TaxTMI RSS Generator https://www.taxtmi.com/news?id=54065 Saroglitazar 1 mg met the EPICS-III trial's composite primary endpoint-clinically meaningful biochemical response based on alkaline phosphatase reductions and bilirubin limits-and a key secondary endpoint of complete ALP normalization at 52 weeks versus placebo. The randomized, double-blind, placebo-controlled Phase 2b/3 trial found saroglitazar generally well tolerated with adverse events balanced between arms. The sponsor plans a U.S. regulatory submission following these topline results, and saroglitazar holds Orphan Drug and Fast Track designations for PBC. News - Sat, 30 Aug 2025 12:01:04 +0530 https://www.taxtmi.com/news?id=54065