Key Takeaways MRK's NDA for its two-drug HIV pill DOR/ISL has been accepted by the FDA, with a decision due in 2026. DOR/ISL showed non-inferiority to current HIV therapies in two pivotal phase III studies. MRK continues HIV research with additional trials and a collaboration with GILD on islatravir combinations.Merck (MRK) announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-daily, oral, two-drug, single-tablet regimen of doravirin ...

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Key Takeaways GILD stock has surged 27.2% in six months, outpacing its industry, sector, and the S&P 500 index. FDA approval of Yeztugo, the first twice-yearly PrEP, strengthens GILD's HIV portfolio and market edge. New liver drug Livdelzi and rising earnings estimates support GILD's growth and dividend sustainability.Shares of Gilead Sciences, Inc. (GILD) have gained 27.2% in the past six months against the industry’s decline of 2.2%. The stock has also outperformed the sector and the S&P 500 index in th ...

Life Sciences & Healthcare Equities Quarterly earnings: Where is the uncertainty? Developed Markets Half full or half empty? Investors remain focused on the uncertain regulatory outlook which in turn makes them more sensitive to the current challenges in the pharma sector, not only growth and profitability but also catalysts and capital deployment. On the other hand, in broad terms, companies seem less nervous about regulation, with commentary that interaction with the US administration is sensible. Further ...

Core Insights - Gilead Sciences, Inc. (GILD) received FDA approval for lenacapavir, branded as Yeztugo, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg [1][7][10] - Yeztugo is the first and only twice-yearly PrEP option available in the United States, representing a significant advancement in HIV prevention [1][10] - The approval was based on late-stage studies, PURPOSE 1 and PURPOSE 2, which demonstrated that ≥99.9% of participants who received Yeztugo remained HIV-negative [2][8] Company Performance - Year to date, GILD shares have increased by 18.6%, contrasting with a 4% decline in the industry [4] - The approval of Yeztugo enhances Gilead's HIV portfolio, especially as its other prevention drug, Truvada, faces generic competition [12] Competitive Landscape - Yeztugo's long-acting dosing aims to improve PrEP uptake by addressing adherence challenges and stigma associated with daily oral medications [7][10] - Gilead's flagship drug, Biktarvy, holds over 51% of the treatment market share in the United States, indicating strong market positioning [11] - The approval of Yeztugo is expected to catalyze uptake among historically underserved populations, providing a competitive advantage over daily oral pills [11][10] Regulatory and Market Developments - Yeztugo was granted Breakthrough Therapy Designation and has also received validation from the European Medicines Agency for marketing authorization [9] - The approval of long-acting injectable forms of PrEP, such as Yeztugo and ViiV Healthcare's Apretude, indicates a growing trend in HIV prevention strategies [13][14]

Core Insights - Zacks Premium provides various tools for investors to enhance their stock market engagement and confidence [1][2] Zacks Style Scores - Zacks Style Scores are indicators that assist investors in selecting stocks likely to outperform the market within 30 days, rated from A to F based on value, growth, and momentum characteristics [3][8] - The Value Score focuses on identifying undervalued stocks using financial ratios like P/E and Price/Sales [4] - The Growth Score emphasizes a company's financial health and future growth potential, analyzing projected and historical earnings and cash flow [5] - The Momentum Score helps investors capitalize on price trends, utilizing recent price changes and earnings estimate shifts [6] - The VGM Score combines all three Style Scores, providing a comprehensive assessment of stocks based on value, growth, and momentum [7] Zacks Rank and Performance - The Zacks Rank is a proprietary model that leverages earnings estimate revisions to guide investors in stock selection, with 1 (Strong Buy) stocks achieving an average annual return of +25.41% since 1988, significantly outperforming the S&P 500 [8][9] - Investors are encouraged to select stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal success [10][11] Company Spotlight: Gilead Sciences - Gilead Sciences specializes in developing treatments for HIV and other diseases, with total sales from its HIV franchise reaching $19.6 billion in 2024, reflecting an 8% year-over-year growth [12] - Gilead holds a 3 (Hold) Zacks Rank and a VGM Score of A, with a Momentum Style Score of B, indicating potential for upward movement [13][14] - Recent analyst revisions for Gilead's earnings estimates have been positive, with the Zacks Consensus Estimate for fiscal 2025 increasing to $7.92 per share and an average earnings surprise of 16.5% [13]

Key Takeaways GILD's HIV studies on GS-1720 and GS-4182 were paused due to CD4 and lymphocyte count concerns. The clinical hold affects two phase II/III trials and three phase I studies of GILD's HIV candidates. Biktarvy and Descovy remain strong performers as GILD pushes forward with lenacapavir for HIV prevention.Gilead Sciences, Inc. (GILD) announced that the FDA has placed a clinical hold on studies on pipeline candidates, GS-1720 and/or GS-4182, for the treatment of HIV.GS-1720 is an investigational ...

Core Viewpoint - Gilead Sciences' stock experienced a decline of over 2% following negative news regarding its investigational HIV treatment program, contrasting with a 0.6% gain in the S&P 500 index [1][2]. Regulatory Action - The U.S. Food and Drug Administration (FDA) has ordered a halt to Gilead's clinical trials involving a two-drug combination aimed at treating HIV [2]. - The FDA's decision was prompted by findings of low CD4+ T-cell levels in some trial participants, although the cause of these deficiencies remains unclear [4]. Drug Information - The two drugs involved are GS-1720, a weekly administered treatment, and GS-4182, a pill version of lenacapavir (commercially known as Sunlenca) [5]. - Gilead is also testing these drugs against its existing HIV treatment, Biktarvy, in various stages of clinical trials [4]. Pipeline and Future Prospects - Despite the FDA's hold, Gilead has indicated that it is developing numerous other HIV combination treatments that are not impacted by this regulatory action [5]. - The company maintains a robust pipeline with 58 investigational programs, suggesting that the FDA's pause may not represent a significant setback for Gilead [6].

Summary of Gilead's Conference Call Company Overview - **Company**: Gilead Sciences - **Industry**: Biotechnology Key Points and Arguments Growth Strategy - Gilead is focusing on three core franchises: virology (HIV), oncology, and inflammation, with a strong emphasis on diversifying beyond virology [3][4] - The company has a robust balance sheet and cash flows, allowing for effective management of operating expenses and investment in growth opportunities [4][5] HIV and Lenacapavir Launch - The launch of lenacapavir for HIV PrEP is imminent, with a PDUFA date set for June 19 [7] - Gilead has been advocating for funding core HIV services, and discussions with the government have been positive regarding support for these programs [8] - Lenacapavir is reported to be 100% effective in preventing HIV, with high community awareness expected to drive uptake [9][10] - The target population for PrEP in the U.S. is approximately 1.2 million, with current users around 400,000, primarily men who have sex with men [13][14] - Gilead aims to improve compliance among current users and expand access to underserved communities [15][16] Reimbursement and Coverage - Gilead expects high insurance coverage for lenacapavir, similar to existing PrEP medications, with an anticipated 70-75% coverage within six months post-launch [22][23] - The company has various support systems in place for individuals with HIV, ensuring access to treatment [24][25] Pipeline and Innovation - Gilead has multiple long-acting HIV programs in development, including a once-a-year injection expected to be available by 2028 [27][28] - The company is also working on alternatives to its leading HIV treatment, Biktarvy, with several programs in various stages of development [32][34] Oncology Developments - Gilead presented significant data at ASCO for Trodelvy in treating triple-negative breast cancer, which could become the new standard of care [36][40] - The oncology business is currently generating over $3 billion annually, with Trodelvy contributing over $1 billion [44] - Gilead is expanding its oncology pipeline with ongoing trials in various cancer types, including lung cancer and multiple myeloma [45][46] Business Development and Future Outlook - Gilead plans to continue investing in late-stage research and development, with a focus on mid-stage acquisitions to complement its portfolio [55][57] - The company is committed to returning value to shareholders through dividends and share buybacks [58] Regulatory Environment - Gilead is actively engaging with the administration regarding potential policy changes, including the MFN executive order, emphasizing the need for a balanced approach to drug pricing [59][60] - The company believes it is less vulnerable to tariffs due to its significant U.S. presence and IP holdings [64][66] Additional Important Content - Gilead's long-term strategy includes exploring novel inflammation targets to complement its existing therapeutic areas [53] - The company is focused on maintaining a competitive edge in the biotechnology sector through innovation and strategic partnerships [54][66]

In February, the U.S. Food and Drug Administration (FDA) accepted Gilead Sciences, Inc.’s GILD New Drug Application (NDA) submissions for lenacapavir — the company’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP).What Happened: The FDA will review the applications under priority review and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 19, 2025.In June 2024, Gilead Sciences shared topline results from an interim ...