GILD · Earnings call · 2026Q3T · Full report

Product / Drug Pipeline Progress

GILEAD SCIENCES, INC. · 2026-10-29 · Importance 23 · Surprise 24

Gilead is advancing oral and injectable HIV treatment options alongside Biktarvy and Bixlenvo, including a planned filing for once-weekly oral islatravir plus lenacapavir. Other programs include weekly oral combinations and long-acting injectable regimens, including a potential twice-yearly treatment for selected virally suppressed patients. In prevention, once-weekly oral lenacapavir was under FDA review, while the company expected a 2027 update on once-yearly intramuscular lenacapavir. Management views the options as a way to expand choice across different dosing preferences and reach people who are not virally suppressed or who could benefit from PrEP.

Key facts

• Gilead's application for monthly oral HIV treatment candidate 3107 was on clinical hold because of unexpected metabolite effects, and the company was working through the hold while developing backup molecules.
• Gilead expected to file islatravir plus lenacapavir with the FDA in 2026, with a regulatory decision in 2027.
• Gilead started a Phase 2 trial of its lenacapavir combination with GS-3242 in October 2026 and expected the Phase 2 trial with GS-1720 to start in early 2027.
• Gilead expected to provide an update from the Phase 3 ASCENT-GYN study around the end of 2026; the study evaluates Trodelvy in advanced or recurrent endometrial cancer.
• Gilead expected a potential anito-cel BLA filing as early as 2027 based on the iMMagine-3 program.
• Gilead expected to initiate the iMMagine-6 and iMMagine-4 studies in early 2027.
• If approved, islatravir plus lenacapavir would be the first once-weekly oral treatment regimen for virally suppressed people with HIV.
• Gilead initiated Phase 3 DAYBREAK 1 and 2 trials in the third quarter of 2026 for lenacapavir plus teropavimab and zinlirvimab.