Jun 18, 2026
The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.
Jun 16, 2026
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
May 01, 2026
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Feb 27, 2026
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
Feb 26, 2026
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
