Gilead's HIV Pipeline Gains Traction With Upcoming FDA Decision For HIV-1 Drug

Core Insights - The FDA has accepted Gilead Sciences' New Drug Application for lenacapavir, an injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis, with a target action date of June 19, 2025 [1] - Gilead's lenacapavir showed 100% efficacy in preventing HIV in cisgender women during the Phase 3 PURPOSE 1 trial, leading to a recommendation to offer the drug to all trial participants [2] - Gilead's stock has increased by approximately 74% since June of the previous year and around 21% year-to-date [3] Company Performance - Gilead is experiencing a turnaround in its stock performance, currently trading at 13.3 times forward earnings, which is below the pharmaceutical industry average of 14 [4] - Concerns exist regarding Gilead's past performance, where a previous stock surge due to hepatitis C treatment success was followed by a decline as demand waned [5] - The company aims to increase U.S. PrEP users to over one million by 2030 to achieve $4 billion in annual sales, with over 400,000 Americans currently using PrEP [6] Market Position - Gilead's HIV drug Biktarvy is protected from generic competition until 2033, positioning the company favorably compared to others facing patent expirations [6] - HIV product sales increased by 6% year-over-year to $4.59 billion in Q1 2025, indicating strong market performance [7] - Potential reductions in federal funding for HIV prevention programs could impact market dynamics, as noted by industry experts [8]