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FDA Grants Priority Review for Bictegravir/Lenacapavir HIV Single-Tablet Regimen

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.

Single-Tablet HIV Regimen Combining Bictegravir and Lenacapavir Meets Phase 3 Trial Endpoints

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.