FDA Grants Priority Review to Gilead's Once-Daily Bictegravir/Lenacapavir HIV Regimen
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.