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FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent player in the biotechnology industry with a market capitalization of $142 billion and annual revenue of $28.75 billion, has announced promising Phase 1 study results for two once-yearly formulations of lenacapavir, an investigational drug for HIV prevention, at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). According to InvestingPro analysis, the company appears overvalued at current levels, though it maintains a "GREAT" financial health score. The study findings, which also appeared in The Lancet, indicate that lenacapavir maintained plasma concentrations above the threshold associated with HIV prevention efficacy for at least 56 weeks. These results will inform the launch of a Phase 3 trial scheduled for the second half of 2025.
The trial included 40 healthy adults at low risk of HIV acquisition, aged 18 to 55 years, with a body mass index of 35.0 kg/m^2 or less. Both formulations of lenacapavir, administered via intramuscular injection, were well tolerated with no new safety signals. The most common adverse event reported was mild injection site pain, which typically resolved within a week.
Additionally, the company presented data from the PURPOSE 1 trial, which showed a preference for twice-yearly lenacapavir injections over once-daily oral HIV prevention methods among participants. With a robust gross profit margin of 78% and strong cash flows, Gilead continues to demonstrate financial strength in its research and development initiatives. InvestingPro subscribers can access 15+ additional exclusive insights about Gilead’s financial performance and market position. Approximately two-thirds of the 2,561 survey respondents preferred the injectable method at Week 52 of the trial, citing better adherence and a feeling of greater protection against HIV.
Further, adolescent pharmacokinetic and safety data from PURPOSE 1, which included participants aged 16 and 17 years, revealed comparable results between adolescents and adults, with no incident HIV infections in the lenacapavir group. This information supports the potential use of twice-yearly lenacapavir for adolescents in need of pre-exposure prophylaxis (PrEP).
Lenacapavir is currently approved in multiple countries for treating adults with multi-drug resistant HIV in combination with other antiretrovirals. Its use for HIV prevention remains investigational, and its safety and efficacy for this purpose have not been established globally.
Gilead’s PURPOSE program, the most comprehensive HIV prevention trial program to date, encompasses five trials worldwide, aiming to assess the safety and efficacy of lenacapavir as a twice-yearly injectable medicine for reducing the risk of HIV. The program reflects Gilead’s commitment to innovation and health equity in the field of HIV prevention and treatment. The company’s stock has shown remarkable strength, with a year-to-date return of 26.89% and trading near its 52-week high of $119.96. For detailed analysis and comprehensive insights, investors can access Gilead’s full Pro Research Report, available exclusively on InvestingPro, along with reports on 1,400+ other top US stocks.
The information in this article is based on a press release statement.
In other recent news, Gilead Sciences has been the focus of several significant developments. Gilead recently reported fourth-quarter earnings that exceeded expectations, with revenue rising by 6% and earnings increasing by 12%. This strong performance was driven by the company’s HIV and liver disease segments, alongside the cancer drug Trodelvy. Meanwhile, Oppenheimer has upgraded its price target for Gilead to $132, citing optimistic projections for Trodelvy, particularly in the treatment of triple-negative breast cancer.
Additionally, Morgan Stanley maintained an Overweight rating on Gilead with a $123 target, following the FDA’s acceptance of the New Drug Application for Lenacapavir, a twice-yearly injectable drug for HIV prevention. This drug has received Priority Review status, with a target action date set for June 2025. The FDA’s review of Lenacapavir, which demonstrated significant efficacy in clinical trials, marks a critical milestone for Gilead’s strategy in HIV prevention.
Furthermore, TD Cowen has raised its price target for Gilead to $100, maintaining a Buy rating after the company’s earnings announcement. Analysts from TD Cowen express confidence in Gilead’s future prospects, particularly with the anticipated launch of Lenacapavir this summer. These developments collectively underscore Gilead’s ongoing efforts in expanding its therapeutic offerings and maintaining a strong financial trajectory.
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