HIV
Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.
Gilead is actively looking for late-stage and de-risked assets for potential deals across various therapeutic spaces, including liver disease, cancer and immunology.
In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”
The U.S. Preventive Services Task Force makes recommendations for preventive services—including Gilead’s twice-yearly HIV PrEP Yeztugo—that insurers must cover. A recently postponed meeting has raised concerns that Health Secretary RFK Jr. could abolish or overhaul the group.
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
Analysts believe that Gilead’s new PrEP drug Yeztugo could reach peak sales of $4.5 billion. Not if GSK has anything to say about it.
The high court found that members of a task force that determines what preventive drugs must be covered can be removed at will by HHS Secretary Robert F. Kennedy Jr.
Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
Gilead underscored its faith in the combo therapy and pledged to work with regulators to resolve the hold, which has paused five clinical trials. Gilead also stressed that the hold does not impact any other assets in its HIV pipeline.
PRESS RELEASES