Gilead Sciences, Inc. (GILD) Reports Higher 52-Week PrEP Persistence With Lenacapavir

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.

Gilead Sciences reported that seladelpar (Livdelzi) achieved alkaline phosphatase (ALP) normalization in 75.4% of patients with primary biliary cholangitis (PBC) in the phase 3 IDEAL trial, compared to 16.1% on placebo. The trial focused on patients with ALP below 1.67 times the upper limit of normal, a group often excluded from prior studies. Gilead plans to discuss the results with global regulators, as seladelpar's accelerated approval depends on confirmatory trials.

Gilead Sciences (GILD) reported Phase 3 IDEAL study results for Livdelzi in primary biliary cholangitis patients, showing 75.4% achieved ALP normalization vs. 16.1% on placebo. The study included 96 adults with specific ALP levels. Gilead plans regulatory discussions and will present data at The Liver Meeting 2026.

Gilead Sciences (GILD) reported that 52.3% of participants in the Phase 3 IDEAL study achieved ALP normalization after one month of Livdelzi treatment, compared to 6.5% on placebo. The response was sustained through Week 52. Serious adverse events were lower in the treatment group (3.1%) than in the placebo group (12.9%).