# Bictegravir 75 mg + lenacapavir 50 mg PDUFA Event: Maintenance treatment of HIV-1 infection

Canonical URL: https://biopharmsignal.com/pdufa-calendar/GILD/bictegravir-lenacapavir-hiv-1

Ticker: GILD

Company: Gilead Sciences

Event date: 2026-08-27

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. PDUFA action date for the once-daily bictegravir and lenacapavir single-tablet regimen NDA.

## Event Timeline

### August 27, 2026 — FDA decision expected

PDUFA action date for the once-daily bictegravir and lenacapavir single-tablet regimen NDA.

[Gilead — NDA acceptance and August 27 action date](https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir)

### April 27, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the application for adults with HIV who are virologically suppressed and assigned the August 27 action date.

[Gilead — FDA Priority Review for BIC/LEN](https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir)

### February 24, 2026 — ARTISTRY-1 and ARTISTRY-2 Week 48 results presented

At CROI 2026, both Phase 3 studies showed that switching to BIC/LEN maintained virologic suppression with efficacy comparable to the control regimens and no significant new safety concerns.

[Gilead — Phase 3 ARTISTRY-1 and ARTISTRY-2 results](https://www.gilead.com/news/news-details/2026/gileads-single-tablet-regimen-of-bictegravir-and-lenacapavir-maintained-virological-suppression-in-people-with-hiv-who-switched-antiretroviral-therapy)

### August 16, 2022 — Phase 3 ARTISTRY-1 study started

The randomized switch study began evaluating once-daily bictegravir/lenacapavir in virologically suppressed adults receiving complex antiretroviral regimens.

[ClinicalTrials.gov — ARTISTRY-1 study record (NCT05502341)](https://clinicaltrials.gov/study/NCT05502341)

## Regulatory Designations

- Priority Review FDA: [Gilead — FDA acceptance and Priority Review](https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir)

## Related Pages

- GILD PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/GILD.md

- GILD company profile: https://biopharmsignal.com/company/GILD.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md