Analyst predicts Gilead’s lenacapavir could revolutionize HIV prevention
US antivirals giant Gilead Sciences (Nasdaq: GILD) recently announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir for HIV prevention.
Lenacapavir was granted Breakthrough Therapy designation for HIV prevention by the FDA in October 2024 and will be reviewed by the agency under priority review. The FDA has set a target action date of June 19, 2025, under the Prescription Drug User Fee Act (PDUFA). If approved, lenacapavir has the potential to revolutionize HIV pre-exposure prophylaxis (PrEP), says pharma analytics company GlobalData.
Along with its 2024 financial results, Gilead indicated that it expects to launch of lenacapavir for HIV PrEP in summer 2025.
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