Gilead Sciences (GILD) secured FDA approval on Wednesday for a highly effective HIV prevention drug.
The twice-yearly injection, previously known as lenacapavir, will be marketed under the brand name Yeztugo. In one clinical trial, none of the more than 2,000 women who received Yeztugo contracted HIV. A separate Phase 3 study involving nearly 2,200 men and transgender women reported only two cases of HIV infection. These results indicate that the biannual shot demonstrated 99.9% effectiveness in preventing HIV.
Daniel O'Day, Gilead's CEO, described it as a "historic day" and expressed hope that Yeztugo could play a pivotal role in ultimately bringing an end to HIV.
"This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention," he said in a statement.
Gilead Sciences shares ended the day unchanged at $108.
Gilead Takes On Its Own Pills
Several preventative options are already available for individuals at risk of contracting HIV. These include Gilead’s daily oral medications, Truvada and Descovy, as well as Apretude, an injection from ViiV Healthcare administered every other month. While HIV infections have declined sharply since their peak in the mid-1980s, new cases continue to emerge at a significant rate in the U.S.
"Every week, nearly 100 Americans die from HIV-related illnesses and more than 700 are newly diagnosed," Gilead Sciences said in an email to Investor's Business Daily. "Globally, there are 1.3 million new injections annually."
However, analysts emphasize that both adoption rates and political factors will play a crucial role.
Under the Affordable Care Act, insurers are required to cover the cost of HIV pre-exposure prophylaxis (PrEP) medications. However, the Supreme Court is set to rule on whether this mandate will remain in place.
Meanwhile, under new Secretary Robert F. Kennedy Jr., the Department of Health and Human Services has recently cut numerous funding programs, including grants dedicated to HIV research. According to NBC News, the 2026 budget proposal calls for a 35% reduction in domestic HIV research funding, which includes shutting down the prevention division of the Centers for Disease Control and Prevention.
Some Headwinds Expected
RBC Capital Markets analyst Brian Abrahams points out that Yeztugo will be priced slightly higher than Descovy, "though we expect meaningful discounting."
Yeztugo may encounter several challenges, such as delayed patient demand for switching, insurance reimbursement hurdles given the availability of lower-cost pills, and the logistical complexities of coordinating biannual injections compared to daily oral medications.
"We remain more conservative on its longer term market opportunity, as we see overall PrEP market given the likely meaningful market share of generic Truvada/step-throughs and overall unwillingness to initiate/adhere to PrEP therapies among high-risk individuals," he said in a note.
He projects peak sales of $3 billion, which falls short of the Street’s more optimistic $4 billion forecast.
