FDA approves Gilead's Yeztugo for twice-yearly HIV prevention, marking a significant breakthrough

From Nasdaq: 2025-06-19 13:30:00

Gilead Sciences, Inc. obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, under the brand name Yeztugo, for the prevention of HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly PrEP option in the U.S.

The FDA approval was granted under Priority Review based on data from studies showing that ≥99.9% of participants who received Yeztugo remained HIV-negative, with shares of GILD gaining 18.6% year to date.

Yeztugo demonstrates zero HIV infections among participants, superiority in preventing HIV infections compared to oral Truvada, and Breakthrough Therapy Designation, with the European Medicines Agency also validating its Marketing Authorization Application for HIV prevention.

Yeztugo’s approval marks a significant breakthrough in HIV prevention, addressing barriers to PrEP adoption and catalyzing uptake among underserved populations, offering a competitive advantage with its twice-yearly administration and broad population coverage.

Gilead’s approval of Yeztugo strengthens its HIV portfolio amid generic competition, with lenacapavir also approved for multi-drug resistant HIV treatment globally, while the FDA also approved a long-acting injectable form of PrEP by ViiV Healthcare, a company partially owned by GSK plc.

Investors can consider Gilead Sciences, Inc., which carries a Zacks Rank #3 (Hold), while better-ranked stocks in the pharma/biotech sector include Novartis and Bayer, both with a Zacks Rank #2 (Buy), showing positive EPS estimate revisions and stock performance year to date.



Read more at Nasdaq: FDA Approves Gilead’s Twice-Yearly Shot for HIV Prevention