Gilead Sciences: FDA accepts GILEAD application for once-weekly oral HIV prevention pill
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U.S. FDA Accepts Gilead’s Application for Investigational Once-Weekly Oral Yeztugo, Potentially the First Long-Acting Pill for HIV Prevention
June 15, 2026 4:34 PM EDTSubmission Supported By Clinical Profile of Lenacapavir, Which Demonstrated High Efficacy in HIV Prevention Across Two Clinical Trials
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Yeztugo® (lenacapavir) 300-mg tablet as a potential once-weekly (QW) oral formulation for the prevention of HIV as pre-exposure prophylaxis (PrEP). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027.
This filing reflects Gileads continued... More
