Gilead Stock Rises as HIV Prevention Injection Meets Study Goals

Gilead Sciences, Inc. GILD announced upbeat results from an interim analysis of a second late-stage study evaluating the use of the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV.Results showed that lenacapavir, administered twice yearly, not only reduced HIV infections by 96% but also demonstrated superiority to Gilead’s daily HIV pill Truvada.The strong results validated lenacapavir’s potential to prevent HIV. Investors were impressed and GILD stock was up 2.74% on Sept. 12, following the announcement.Shares of the company have risen 2.7% year to date against the industry’s decline of 0.8%.Image Source: Zacks Investment ResearchGILD’s Lenacapavir Shines in Phase IIIThe double-blind, multicenter, randomized study phase III study, PURPOSE 2, is evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) versus once-daily oral Truvada and background HIV incidence (bHIV) in more than 3,200 cisgender men, transgender men, transgender women and gender non-binary individuals aged 16 years or older.Results showed that 99.9% of the participants did not acquire HIV infection in the lenacapavir group. Only two tested positive among 2,180 participants.The results also demonstrated the superiority of twice-yearly lenacapavir over bHIV, with 96% relative risk reduction. Nine cases were reported among 1,087 individuals in the Truvada group. Twice-yearly lenacapavir was 89% more effective than once-daily Truvada. Both lenacapavir and Truvada were generally well-tolerated and no significant or new safety concern was identified.The PURPOSE 2 study met its key efficacy endpoint of the superiority of twice-yearly lenacapavir over both bHIV (primary endpoint) and once-daily oral Truvada (secondary endpoint) for PrEP.  The success of the study was confirmed by the independent Data Monitoring Committee (“DMC”) in its interim analysis.Consequently, the DMC recommended Gilead to stop the blinded phase of the trial and offer open-label lenacapavir to all participants.How Will the Success of Lenacapavir Place GILD?PURPOSE 2 is the second phase III study to demonstrate superior efficacy for twice-yearly lenacapavir for the investigational use of HIV prevention as PrEP.In June 2024, Gilead reported that the PURPOSE 1 trial evaluated lenacapavir for PrEP among cisgender women in sub-Saharan Africa. The trial was also unblinded early because it met its key efficacy endpoints.The success of these trials should enable GILD to initiate a series of global regulatory filings by the end of 2024.A potential approval of twice-yearly lenacapavir for PrEP will make this groundbreaking treatment available to multiple populations and communities around the world in grave need of additional HIV prevention options.GILD expects the initial launch of the first and only twice-yearly HIV prevention choice in 2025.PrEP, or pre-exposure prophylaxis, is a medicine taken by people at risk for HIV to prevent acquiring the disease from sex or injection drug use. PrEP can stop HIV from taking hold and spreading throughout the body. PrEP can be in the form of pills or shots.At present, there are two FDA-approved daily oral medications for PrEP — Truvada and Descovy.Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP.The strong results increase the probability of lenacapavir’s approval that should further solidify GILD’s HIV franchise. Lenacapavir has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population.Gilead is a dominant player in the HIV market. The company developed the first single-tablet regimen to treat HIV, the first antiretroviral for PrEP, to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice yearly.Lenacapavir is already approved under the brand name Sunlenca in the United States for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant infection.A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare’s Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms for PrEP to reduce the risk of sexually acquired HIV.ViiV Healthcare is a global specialist HIV company, majorly owned by GSK plc GSK, with Pfizer and Shionogi as shareholders.Apretude is given first as two initiation injections administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug.GSK is a key competitor for GILD in the HIV market. GSK posted 13% growth in HIV sales in the second quarter, driven by strong patient demand for two drug regimens — Dovato and Juluca — and long-acting drugs (Cabenuva and Apretude).GILD’s Zacks Rank & Stocks to ConsiderGilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks from the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31 during the said time frame. Year to date, shares of KRYS have risen 57.7%.In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimate for 2025 has narrowed from $1.71 to $1.51 during the same time frame. Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Krystal Biotech, Inc. (KRYS): Free Stock Analysis Report Fulcrum Therapeutics, Inc. (FULC): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks