Gilead's Lenacapavir Advances: FDA Accepts Weekly Oral PrEP Application, Global Access Expands
Jun 16, 2026
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.