GILD · News · 20260916N
HIV PrEP Regulatory Expansion
GILEAD SCIENCES, INC. · 2026-09-16 · Importance 31 · Surprise 42 · In source text
Gilead expanded six royalty-free voluntary licensing agreements for investigational once-yearly lenacapavir for HIV pre-exposure prophylaxis to 120 high-incidence countries, primarily low- and lower-middle-income markets. The agreements are intended to support manufacturing readiness, technology transfer and future supply planning while the Phase 3 PURPOSE 365 trial evaluates the drug’s efficacy. Gilead also entered a Pan American Health Organization agreement covering twice-yearly lenacapavir access in 14 additional Latin American and Caribbean countries. The once-yearly formulation has not yet received regulatory approval, creating a regulatory and commercialization dependency for the access strategy.
Key facts
- Gilead expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir to include investigational once-yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP). source
- Gilead's PAHO deal expands twice-yearly lenacapavir access across Latin America and the Caribbean, adding 14 countries to its global access strategy. source
- Gilead expanded its partnership with the U.S. State Department and entered a new agreement with the Pan American Health Organization for the twice-yearly version of lenacapavir. source
- MacroGenics announced an expanded collaboration with Gilead. source
- Those six royalty-free voluntary licensing agreements cover 120 high-incidence countries (which are primarily low- and lower-middle-income). source
- The Phase 3 PURPOSE 365 trial is ongoing evaluating the once-yearly lenacapavir drug's effectiveness as a pre-exposure prophylaxis. source
- Gilead Sciences insider Johanna Mercier sold 3,000 shares of company stock worth $432,660.00 on September 15th, reducing her direct ownership to 116,684 shares. source
- Gilead's stock rose 0.9% to $147.68 and the company recently declared a quarterly dividend of $0.82 per share. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | negative | committed | — | Gilead expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir to include investigational once-yearly… |
| revenue | positive | committed | — | Gilead's PAHO deal expands twice-yearly lenacapavir access across Latin America and the Caribbean, adding 14 countries to its global… |
| revenue | positive | committed | — | Gilead expanded its partnership with the U.S. State Department and entered a new agreement with the Pan American Health Organization for… |
| revenue | positive | probable | — | MacroGenics announced an expanded collaboration with Gilead. |