Gilead Sciences, Inc.: New Data Show Twice-Yearly Lenacapavir Achieved Nearly Twice the One-Year Persistence of Daily Oral F/TDF in HIV Prevention

Gilead's twice-yearly lenacapavir showed 85.6% persistence at 52 weeks vs. 46.3% for daily F/TDF in HIV prevention study. No HIV acquisitions occurred in the lenacapavir group. The study highlights the potential of long-acting HIV prevention options to improve persistence and effectiveness.

Gilead Sciences reported that its Phase 2 PURPOSE 5 trial showed higher 52-week persistence with lenacapavir compared to F/TDF for HIV prevention. No HIV cases occurred in the lenacapavir group, while one case was reported in the F/TDF group. This adds to Gilead's lenacapavir data but is not a regulatory or commercial milestone.

The FDA granted tentative approval to a $40 generic version of lenacapavir, an HIV prevention injection, developed by Dr. Reddy’s Laboratories. The branded version costs over $28,000 annually in the U.S. The generic could reach 120 low- and middle-income countries under licensing agreements with Gilead Sciences. The UK approved the branded version but faces NHS coverage hurdles.

Gilead Sciences' Livdelzi (seladelpar) showed significant reduction in alkaline phosphatase (ALP) levels in a Phase III trial for primary biliary cholangitis (PBC), with 75.4% of patients achieving normal ALP levels vs. 16.1% on placebo. The drug was deemed safe and tolerable, with no new safety concerns. Gilead plans to discuss these results with global regulators, potentially expanding Livdelzi's approval and reaching a larger PBC patient population.

Gilead (GILD) reported Phase 3 IDEAL study results showing Livdelzi achieved 75.4% ALP normalization in PBC patients, vs. 16.1% for placebo. The study included 96 adults with PBC and ALP levels below typical trial thresholds. Gilead plans regulatory discussions and presented findings at The Liver Meeting 2026. GILD stock is down 1.96% to $171.06.

Vir Bio (VIR) reported Q3 2026 progress, including Phase III hepatitis delta trials with data expected this quarter and next year. VIR-5500 received FDA Fast Track designation for late-line mCRPC. The company also announced a research collaboration with Gilead, validating its PRO-XTEN platform. VIR-5818's Phase I trial is ongoing with refined study design based on FDA feedback.