FDA grants priority review to Gilead's once-daily bictegravir plus lenacapavir HIV pill

The FDA accepted Gilead's new drug application for a once-daily single tablet of bictegravir 75 mg and lenacapavir 50 mg and granted priority review. The action date is August 27, 2026. The filing targets adults who are already virologically suppressed and rests on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials.

• Priority review granted; PDUFA action date August 27, 2026
• Single tablet of bictegravir 75 mg and lenacapavir 50 mg, once daily
• Supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 in virologically suppressed adults
• Gilead says it would be the smallest single-tablet HIV regimen if approved