WS Investor
16 Sep 2026, 15:20
Gilead Expands Access Plans for Once-Yearly HIV Prevention Drug
Gilead Sciences (NASDAQ: GILD) is expanding its global access strategy for investigational once-yearly lenacapavir, potentially offering HIV prevention with just one injection per year if the treatment succeeds in clinical trials and receives regulatory approval.
The company expanded six royalty-free voluntary licensing agreements to cover the once-yearly formulation, supporting manufacturing readiness and future supply across 120 high-incidence, primarily low- and lower-middle-income countries. Partners include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero and Viatris subsidiary Mylan.
The drug is currently being evaluated in the Phase 3 PURPOSE 365 study, which is testing whether a single intramuscular dose can maintain HIV-preventive drug concentrations for a full 52 weeks. The once-yearly formulation remains investigational and has not been approved by any regulatory authority.
Lenacapavir is already approved in multiple countries in a twice-yearly formulation for HIV prevention. Extending the dosing interval to once a year could strengthen Gilead’s HIV franchise by reducing the frequency of treatment and potentially addressing adherence and access barriers associated with more frequent PrEP regimens.
Gilead Sciences (NASDAQ: GILD) is expanding its global access strategy for investigational once-yearly lenacapavir, potentially offering HIV prevention with just one injection per year if the treatment succeeds in clinical trials and receives regulatory approval.
The company expanded six royalty-free voluntary licensing agreements to cover the once-yearly formulation, supporting manufacturing readiness and future supply across 120 high-incidence, primarily low- and lower-middle-income countries. Partners include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero and Viatris subsidiary Mylan.
The drug is currently being evaluated in the Phase 3 PURPOSE 365 study, which is testing whether a single intramuscular dose can maintain HIV-preventive drug concentrations for a full 52 weeks. The once-yearly formulation remains investigational and has not been approved by any regulatory authority.
Lenacapavir is already approved in multiple countries in a twice-yearly formulation for HIV prevention. Extending the dosing interval to once a year could strengthen Gilead’s HIV franchise by reducing the frequency of treatment and potentially addressing adherence and access barriers associated with more frequent PrEP regimens.
