Gilead Sciences Receives FDA Approval for Twice-Yearly HIV Preventive Therapy

Gilead Sciences, Inc. (GILD) has received FDA approval for Yeztugo, the world's first twice-yearly HIV preventive therapy. This breakthrough strengthens Gilead's leadership in antiviral innovation and signals a transformative step in global health and market growth. The company's HIV portfolio, including Biktarvy, has shown a 7% year-over-year sales increase. Momentum is building globally, with the European Medicines Agency recommending approval for lenacapavir, Gilead's twice-yearly HIV prevention drug.

Gilead Sciences, Inc. (GILD) has made a significant stride in the fight against HIV with the FDA approval of Yeztugo, the world's first twice-yearly HIV preventive therapy. This breakthrough strengthens Gilead's leadership in antiviral innovation and signals a transformative step in global health and market growth. The company's HIV portfolio, including Biktarvy, has shown a 7% year-over-year sales increase, reflecting the growing demand for effective HIV prevention and treatment solutions.

Yeztugo, an injectable HIV-1 capsid inhibitor, received FDA approval in June and is now authorized for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents who weigh at least 35kg. The European Medicines Agency (EMA) has recommended approval for lenacapavir, the active ingredient in Yeztugo, following a rigorous review process [1].

The approval of Yeztugo comes on the heels of positive clinical trial results that demonstrated its high efficacy and safety. In the PURPOSE 1 and PURPOSE 2 trials, Yeztugo showed a 100% reduction in HIV infections compared to the once-daily oral Truvada in cisgender women in sub-Saharan Africa and a 99.9% reduction in cisgender men and gender-diverse people, respectively [1]. The data from these trials, published in The New England Journal of Medicine, underscored the potential of Yeztugo as a transformative HIV prevention option.

Gilead's global access strategy for Yeztugo is designed to prioritize speed and efficiency, with regulatory filings ongoing in several countries, including Australia, Brazil, Canada, South Africa, and Switzerland. The company is also preparing submissions in Argentina, Mexico, and Peru. Additionally, Gilead has announced a strategic partnership with The Global Fund to supply Yeztugo for PrEP to up to two million people in low- and lower-middle-income countries [1].

The approval of Yeztugo is a testament to Gilead's commitment to addressing the urgent unmet need in HIV prevention. With around 25,000 new HIV diagnoses in the EU and European Economic Area every year, the introduction of a twice-yearly PrEP option could significantly impact the HIV epidemic. Jean-Michel Molina, MD, Professor of Infectious Diseases at Université Paris Cité, highlighted the potential of Yeztugo in reducing new infections and making real progress toward ending the HIV epidemic [1].

As Gilead continues to expand its HIV portfolio, investors and financial professionals should closely monitor the company's progress in securing regulatory approvals and market access for Yeztugo. The success of Yeztugo could further bolster Gilead's market growth and position it as a leader in HIV prevention and treatment.

References:
[1] https://www.gilead.com/news/news-details/2025/european-commission-authorizes-twice-yearly-yeytuo-lenacapavir-for-hiv-prevention