Upcoming FDA decision · February 2, 2027
Lenacapavir PDUFA date: FDA decision expected February 2, 2027
107 days to goGilead Sciences, Inc. (GILD) →
The FDA is expected to decide on Lenacapavir from Gilead Sciences, Inc. in HIV pre-exposure prophylaxis (PrEP) by the PDUFA target action date of February 2, 2027. For HIV pre-exposure prophylaxis (PrEP). sNDA filing. Extracted from SEC filing: EXHIBIT 99.1
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.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
February 2
Target action date
Phase 3
Stage
Verified
Date confidence
2
FDA designations
FDA designations
Breakthrough Therapy Fast Track
Questions about this FDA decision
- When is the PDUFA date for Lenacapavir?
- The FDA's PDUFA target action date for Lenacapavir is February 2, 2027. The FDA can act before that date, and the review can be extended.
- What is Lenacapavir being reviewed for?
- The application under FDA review covers HIV pre-exposure prophylaxis (PrEP).
- Which company is developing Lenacapavir?
- Gilead Sciences, Inc. (GILD).
- Does Lenacapavir have FDA expedited designations?
- Yes: Breakthrough Therapy, Fast Track.
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).