Upcoming FDA decision · October 20, 2026
Lenacapavir PDUFA date: FDA decision expected October 20, 2026
27 days to goGilead Sciences, Inc. (GILD) →
The FDA is expected to decide on Lenacapavir from Gilead Sciences, Inc. in HIV Prevention by the PDUFA target action date of October 20, 2026. For HIV-1 infection. BLA filing. Extracted from SEC filing: 8-K
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
October 20
Target action date
Phase 3
Stage
Detected
Date confidence
2
FDA designations
FDA designations
Breakthrough Therapy Fast Track