GILD

bictegravir and lenacapavir (BIC LEN)

Name: GILEAD SCIENCES, INC. FDA PDUFA Decision
Start: 2026-08-27

FDA PDUFA Target Action Date · GILEAD SCIENCES, INC.

Thursday, August 27, 2026

Approved

approved

Note: Approved 2026-08-27 as BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) (ORIG NDA221443). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 0d from the PDUFA date.

Drug Information

Drug Name: bictegravir and lenacapavir (BIC LEN) (CT.gov)
Application Type: NDA
Indication: virologically suppressed people with HIV
Approved As: bictegravir and lenacapavir (BIC LEN)

Filing Details

Company: GILEAD SCIENCES, INC. →
Stock Ticker: GILD
SEC CIK: 0000882095
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore GILEAD SCIENCES, INC.

View GILEAD SCIENCES, INC.'s full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue