FDA Grants Fast Track Designation to Armata’s AP-SA02 for Staph Bacteremia

Gilead Sciences has reached an agreement with the Pan American Health Organization to expand access to its twice-yearly HIV-prevention drug lenacapavir across Latin America and the Caribbean, creating a regional procurement pathway for 14 countries including Brazil, Mexico, Argentina, Colombia and Peru that were outside Gilead's existing voluntary generic-licensing arrangements. Availability will still depend on individual countries' regulatory approvals and decisions to adopt the drug. Gilead expects lenacapavir to generate about $1 billion in 2026 sales, and reported 12% year-over-year HIV sales growth in the second quarter of 2026, with Yeztugo sales reaching $232 million, above the $210 million analyst estimate, after which the company raised its expected 2026 HIV-product sales growth to 9%-10%. Reuters reported that new HIV infections in Latin America and the Caribbean rose 13% between 2010 and 2024, and that lenacapavir demonstrated nearly 100% efficacy in large prevention trials, while Yeztugo carries a U.S. annual list price above $28,000. Gilead has already granted royalty-free voluntary licenses to generic manufacturers for resource-limited countries and is still discussing possible local production with Brazil's Health Ministry, so the expanded access may come with lower pricing and margins than in wealthier markets.

Chiome Bioscience announced that the results of joint research with a research group from the Infectious Pathology Division of the National Institute of Infectious Diseases at the National Center for Global Health and Medicine has been published in the international academic journal Protein Science. In the study, the researchers designed a unique antigen targeting influenza virus that utilizes molecular mimicry by anti-idiotype antibodies, and showed that it can induce antibodies in inoculated animals that react broadly to multiple types of the virus. Following the announcement, shares of Chiome Bioscience widened their gains in the afternoon session and are currently at 94 yen, up 6 yen from the previous day.