Gilead Sciences won Food and Drug Administration approval Wednesday for a highly-effective drug to prevent HIV infection.
The twice-yearly shot, formerly called lenacapavir, will sell under the brand name Yeztugo. In one test, none of the more than 2,000 women who received Yeztugo contracted HIV. A second Phase 3 study included nearly 2,200 men and transgender women. In that group, there were just two HIV infections. That means the every-six-months shot proved 99.9% effective.
Daniel O'Day, Gilead's chief executive, called it a "historic day," and suggested Yeztugo could help finally "end 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 stock closed flat at 108.
Gilead Takes On Its Own Pills
There are already several options for patients at risk of contracting HIV. They include daily pills from Gilead called Truvada and Descovy, as well as an every-other-month shot from ViiV Healthcare called Apretude. Infections have fallen dramatically from their peak in the mid-1980s, but they still occur at a marked pace 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."
But analysts say uptake and politics will be key.
Under the Affordable Care Act, insurance companies must pay for the cost of HIV prophylactic exposure, or PrEP, drugs. But the Supreme Court is due to make a decision on whether to maintain that requirement of the ACA.
Meanwhile, the Department of Health and Human Services — under new secretary Robert F. Kennedy Jr. — recently scrapped numerous funding programs, including grants for HIV research. The 2026 budget request seeks to eliminate 35% of domestic funding for HIV research, according to NBC News. That includes closing the Centers for Disease Control and Prevention's prevention division.
Some Headwinds Expected
RBC Capital Markets analyst Brian Abrahams notes Yeztugo will cost slightly more than Descovy, "though we expect meaningful discounting."
Yeztugo could face some headwinds, including pent-up demand from patients to switch, insurance reimbursement while lower-cost pills are available, and the logistics of scheduling doctor's visits for twice-annual shots vs. daily pills.
"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 estimates $3 billion in peak sales, lower than the Street's broader forecast for $4 billion.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
