Key Takeaways GSK's Specialty Medicines sales jumped 17% in Q1 2025, driven by HIV and oncology product strength. GSK expects low double-digit Specialty Medicines growth in 2025 despite IRA related headwinds. New approvals like Nucala for COPD and strong launches like Blujepa support the growth trajectory.GSK plc’s (GSK) Specialty Medicines segment includes medicines that prevent and treat diseases like HIV, cancer, asthma and immune-inflammation diseases like lupus. Specialty Medicines now represents clo ...

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]

Key Takeaways GSK's Specialty Medicines unit drove 19% growth in 2024 and 17% in Q1 2025, led by HIV and oncology drugs. New U.S. approvals and strong research momentum support GSK's pipeline across respiratory, HIV and oncology. GSK trades at a forward P/E of 8.63, below the industry average, and continues to outperform peers and market.GSK (GSK) stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an opti ...

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 ...

Gilead Sciences, Inc. (GILD) and GSK (GSK) are pioneers in the human immunodeficiency virus (HIV) treatment space.Gilead Sciences is a dominant player in the HIV market with market-leading treatments. HIV drug sales accounted for 69% of total product sales in the first quarter of 2025. GILD’s diverse portfolio also includes drugs for liver, hematology/oncology and inflammation/respiratory diseases.GSK, too, has a strong HIV portfolio in the industry. HIV drug sales accounted for 23% of total sales in the fi ...