Overview

• The FDA cleared lenacapavir (Yeztugo) on June 18, 2025, for HIV prevention in adolescents and adults weighing at least 35 kg.
• In a Phase 3 trial among women and girls in sub-Saharan Africa the injection achieved 100% protection, and in a global study it reduced infections by 96–99.9%.
• Gilead set a U.S. list price near $28,218 per year and launched copay assistance and free-drug programs for uninsured patients.
• The company granted royalty-free licenses to six generic manufacturers to supply low-cost versions in 120 low- and lower-middle-income countries.
• Threatened cuts to federal HIV prevention and Medicaid funding could limit access for vulnerable and high-risk populations.