GILD · News · 20260917N

HIV PrEP Regulatory Expansion

GILEAD SCIENCES, INC. · 2026-09-17 · Importance 34 · Surprise 42

Gilead expanded six royalty-free voluntary licensing agreements for investigational once-yearly lenacapavir to generic manufacturers covering 120 high-incidence, resource-limited countries. The agreements are intended to support manufacturing readiness and supply before Phase 3 results and potential regulatory approvals, potentially broadening future HIV prevention product volumes while limiting royalty revenue in covered markets. Gilead also signed an agreement with the Pan American Health Organization to accelerate access to twice-yearly lenacapavir for HIV prevention in 14 countries across Latin America and the Caribbean. The access initiatives could affect future product mix and access economics, although the reports disclose no dollar value or quantified margin impact.

Key facts

• Gilead's once-yearly formulation of lenacapavir is described as investigational and is currently in Phase 3 trials. source