Gilead Unveils Long-Term Data From Seladelpar In Patients With Rare Liver Disease

Core Insights - Gilead Sciences, Inc. announced positive interim results from the Phase 3 ASSURE study for Livdelzi, showing 81% of participants with primary biliary cholangitis (PBC) achieved a composite biochemical response [1] - The FDA granted accelerated approval for Livdelzi in August for PBC treatment, indicating its potential in the market [3] Efficacy and Safety Data - In the ASSURE study, 41% of participants achieved normalization of alkaline phosphatase (ALP) levels, a key liver function biomarker [2] - Livdelzi demonstrated a significant reduction in ALP levels compared to placebo, with a decrease of approximately 35% in participants with cirrhosis and 43.5% in those without cirrhosis [3] - The treatment was generally well tolerated, with no new safety signals reported over three years of exposure [2] Additional Findings - Secondary analysis from the RESPONSE trial indicated that Livdelzi led to near resolution of pruritus in 26.5% of participants with a baseline NRS of ≥4 and 18.8% with NRS ≥7, compared to 0% in the placebo group [3] Market Reaction - Following the announcement, Gilead's stock price decreased by 3.48%, closing at $88.90 [4]