Gilead Sciences press release
FOSTER CITY, Calif., June 15, 2026 — 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.
The submission is supported by the robust and established clinical profile of lenacapavir for PrEP, based on results from the PURPOSE 1 and PURPOSE 2 trials, which demonstrated high efficacy across diverse global populations, including cisgender women, cisgender men and gender-diverse people. Lenacapavir oral tablets are already approved for use within the Yeztugo regimen as an initial loading dose and as a bridge therapy when administration of the every-six-month injections are delayed. If approved, once-weekly oral Yeztugo could become the first long-acting oral PrEP option.
Read the full press release here.
Source : Gilead Sciences
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