Gilead announces U.S. FDA accepted NDA submission for bictegravir, lenacapavir

Gilead (GILD) Sciences announced the U.S. Food and Drug Administration, FDA, accepted its New Drug Application, NDA, submission for bictegravir 75 mg/lenacapavir 50 mg – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed. The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act action date of August 27, 2026.