Topline
Yeztugo, a twice-a-year antiviral shot to prevent HIV, was approved by the Food and Drug Administration on Wednesday, marking a major advance in battling AIDS.
Yeztugo was approved by the FDA Wednesday.
Key Facts
The drug (which has the generic name lenacapavir) will become available in the U.S. following the approval, though it’s unclear who will initially have access to the drug.
Gilead Sciences CEO Daniel O’Day said in a statement the approval could help make the goal of ending HIV “a reality,” saying the injectable “offers a very real opportunity to help end the HIV epidemic.”
Yeztugo has an annual list price of $28,218 before insurance, a figure similar to prices of other branded medications approved for the same use, according to CNBC.
Gilead’s stock spiked following the approval, though it quickly dropped back down to roughly flat on the day—in line with broader market movements.
The approval comes after two clinical Yeztugo trials showed the drug could nearly prevent all HIV infections, with zero infections among 2,134 participants in one trial and two infections among 2,179 participants in another trial.
Yeztugo is Gilead’s latest pre-exposure treatment for HIV prevention, as the pharma company has also produced daily oral pills (Truvada and Descovy) to reduce the risk of HIV infection.
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Tangent
Gilead’s stock has nearly doubled in the past year, trading around $63 per share one year ago. The pharmaceutical company has benefited from strong earnings and sales of its HIV drugs , exceeding Wall Street expectations with a 6% year-over-year revenue increase reported in its final quarter of 2024.
Big Number
1.2 million. That is the number of people in the U.S. estimated to have HIV in 2022, with around 31,800 people contracting the virus that year, according to the Centers for Disease Control and Prevention.
Key Background
HIV, which stands for human immunodeficiency virus, targets the body’s immune system and can lead to AIDS (acquired immunodeficiency syndrome) without treatment. HIV has no cure, but advancements in treatments allow those with HIV to live long lives. Meanwhile, pre-exposure treatments made by companies like Gilead have proven effective in preventing transmission of the virus. However, staffing and funding cuts by President Donald Trump against the CDC have impacted HIV research and prevention efforts, NBC News reported, noting cuts have impacted surveillance of HIV among gay men, a demographic disproportionately affected by HIV.
Further Reading
Trump administration axes more than $125M in LGBTQ health funding, upending research field (NBC News)
Source: https://www.forbes.com/sites/antoniopequenoiv/2025/06/18/fda-greenlights-twice-a-year-hiv-prevention-drug/