Gilead presents PBC trial data, plans regulatory discussions

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.

Gilead Sciences (GILD) and its subsidiary Kite will present data on anito-cel and Yescarta at the ASH meeting in December 2026. The data includes 18-month follow-up on anito-cel for multiple myeloma and 5-year follow-up on Yescarta for lymphoma. Anito-cel is under FDA review with a decision expected December 23, 2026. The company also announced data on investigational gamgertamig for autoimmune diseases.

Gilead's Kite unit will present long-term data on its lymphoma treatment Yescarta and new data on anito-cel for multiple myeloma at ASH 2026. The iMMagine-1 trial data supports the FDA review of anito-cel, with a PDUFA target date of December 23, 2026. Yescarta's five-year follow-up data will provide long-term evidence for its use in high-risk large B-cell lymphoma.

Jefferies maintained a Buy rating and $196 price target for Gilead Sciences (GILD), citing a potential $1.5B revenue headwind from Biktarvy's pricing under the Inflation Reduction Act in 2028, but expects offsets to reduce this impact. Gilead reported Q3 2026 earnings of $2.55 per share and $8.3B revenue, exceeding estimates. Analysts UBS, Bernstein, TD Cowen, and BMO raised their price targets following strong results.