Gilead’s twice-yearly HIV prevention shot effective across diverse groups

FOSTER CITY - Gilead Sciences, Inc. (NASDAQ:GILD), a prominent biotechnology company with $28.73 billion in revenue and an impressive 78.29% profit margin, announced new Phase 3 data showing its twice-yearly HIV prevention injection Yeztugo (lenacapavir) demonstrated efficacy and tolerability across diverse populations, including pregnant women, adolescents, and young adults. According to InvestingPro analysis, the company maintains excellent financial health with strong cash flows to support its research initiatives.

The data, presented at the International AIDS Society Conference in Kigali, Rwanda, revealed no new HIV infections among 184 pregnant or lactating women receiving Yeztugo in the PURPOSE 1 trial. Similarly, zero infections were reported among young people aged 16-25 in PURPOSE 1, with only two infections in this age group in the PURPOSE 2 trial.

Researchers also presented modeling data showing supplemental dosing recommendations for people taking tuberculosis medications alongside Yeztugo. The drug’s safety profile was similar between pregnant and non-pregnant women, with minimal exposure detected in breastfed infants.

Survey data from both trials indicated more than 75% of participants preferred twice-yearly injectable prevention over daily oral medication, with over half reporting a strong preference. Key reasons included feeling more protected from HIV (69%) and greater confidence in not missing doses (77%).

"The PURPOSE program set a new standard for innovative, intentional inclusion by ensuring we would have safety and efficacy data in these populations from the outset," said Linda-Gail Bekker, Director of the Desmond Tutu HIV Center at the University of Cape Town.

The U.S. Food and Drug Administration approved Yeztugo on June 18, 2025, as the first twice-yearly HIV prevention option. Gilead has submitted applications to regulatory authorities in multiple countries including Australia, Brazil, Canada, and across Europe. Trading near its InvestingPro Fair Value, Gilead offers investors a solid 2.88% dividend yield and has raised its dividend for 10 consecutive years. For detailed analysis of Gilead’s financial outlook and growth potential, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.

The company recently announced a partnership with The Global Fund to supply lenacapavir doses at no profit to reach up to two million people over three years in supported countries.

This information is based on a press release statement from Gilead Sciences.

In other recent news, Gilead Sciences has received FDA approval for Yeztugo, an injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), marking it as the first and only twice-yearly option available in the United States for HIV prevention. This regulatory approval has led firms like BMO Capital to reiterate an Outperform rating and a $120.00 price target, highlighting the potential for significant growth in Gilead’s PrEP business. Bernstein also reiterated an Outperform rating, projecting substantial revenue growth for Yeztugo by 2030, despite potential initial launch challenges. In another development, Gilead has partnered with Kymera Therapeutics to develop a novel cancer treatment targeting cyclin-dependent kinase 2 (CDK2). The agreement could see Kymera receive up to $750 million in payments, with Gilead gaining global rights to the products if it exercises its option. Additionally, RBC Capital has raised its price target on Gilead to $95, citing promising market opportunities for lenacapavir, though it remains cautious about the overall PrEP market growth. These developments indicate Gilead’s strategic focus on expanding its portfolio in both HIV prevention and cancer therapeutics.

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