Gilead Stock Rises as HIV Prevention Injection Meets Study Goals

Core Insights - Gilead Sciences, Inc. announced positive interim results from a late-stage study of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, showing a 96% reduction in HIV infections compared to daily Truvada [1][3] - The study demonstrated that 99.9% of participants in the lenacapavir group did not acquire HIV, with only two infections among 2,180 participants [3] - Gilead's stock rose 2.74% following the announcement, reflecting investor confidence in the drug's potential [1] Study Details - The PURPOSE 2 study involved over 3,200 participants, including cisgender men, transgender individuals, and gender non-binary individuals aged 16 and older [3] - The study met its primary efficacy endpoint, confirming lenacapavir's superiority over both background HIV incidence and Truvada [4] - The independent Data Monitoring Committee recommended stopping the blinded phase of the trial and offering lenacapavir to all participants [4] Market Implications - The success of lenacapavir in the PURPOSE 2 study positions Gilead to initiate global regulatory filings by the end of 2024, with a potential launch in 2025 [6] - Lenacapavir's twice-yearly administration offers a competitive advantage over daily oral medications, addressing a broader population in need of HIV prevention options [7] - Gilead is a dominant player in the HIV market, having developed the first single-tablet regimen and the first long-acting injectable treatment [7] Competitive Landscape - GSK's Apretude, another long-acting injectable for HIV prevention, was approved by the FDA in 2021, representing a key competitor for Gilead [8] - GSK reported a 13% growth in HIV sales in the second quarter, driven by demand for its long-acting drugs [8]