Gilead Sciences said the U.S. FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300 mg tablets as a potential once-weekly oral PrEP option for HIV prevention. The agency assigned a Prescription Drug User Fee Act action date of February 2, 2027, placing the program on a defined regulatory timeline. Lenacapavir is already known in HIV treatment programs, but an oral, long-acting prevention regimen would represent a major practical shift for adherence compared with current prophylaxis options. The filing acceptance signals FDA has accepted the submission for substantive review, setting up the next decision point later this decade.