Gilead Sciences New Supplemental Dug Application Accepted By FDA For Yeztugo 300-Mg Tablet; Regulator Sets Feb. 2, 2027 As Prescription Drug User Fee Act Action Date

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.