Gilead Sciences, Inc.
bictegravir and lenacapavir
virologically suppressed people with HIV
Countdown
52days
FDA decision · Aug 27, 2026
What's at stake
The FDA's approval decision on bictegravir and lenacapavir for virologically suppressed people with HIV is due Aug 27, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“Announced U.S. Food and Drug Administration (“FDA”) accepted New Drug Application for bictegravir and lenacapavir (“BIC/LEN”) for virologically suppressed people with HIV under priority review, with a Prescription Drug User Fee Act (“PDUFA””