Gilead's Livdelzi Achieves 75% ALP Normalization In Phase 3 IDEAL Study; Stock Down

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%).

Gilead's Livdelzi showed 75.4% of patients achieving normal liver marker levels after 52 weeks, vs. 16.1% on placebo, in a Phase 3 trial for PBC. Results will be presented at The Liver Meeting 2026 and published in the Journal of Hepatology. Gilead plans to engage with global regulators based on these findings.

Gilead Sciences (GILD) reported 16% sales growth excluding Veklury in Q3 2026. The stock rose 47.4% since Oct. 2025. CMS set Biktarvy's Medicare price at $2,600, 38% below list price, expected to reduce 2028 revenue by $1.5B. Biktarvy accounted for $14.3B of 2025 sales. GILD stock trades at 6.8x sales, near its 1-year high.