# YEZTUGO (lenacapavir), once-weekly oral tablet PDUFA Event: HIV pre-exposure prophylaxis

Canonical URL: https://biopharmsignal.com/pdufa-calendar/GILD/yeztugo-once-weekly-oral-hiv-pre-exposure-prophylaxis

Ticker: GILD

Company: Gilead Sciences

Event date: 2027-02-02

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sNDA

FDA decision expected. FDA assigned February 2, 2027 as the PDUFA action date for the supplemental NDA for a once-weekly oral YEZTUGO formulation for HIV pre...

## Event Timeline

### February 2, 2027 — FDA decision expected

FDA assigned February 2, 2027 as the PDUFA action date for the supplemental NDA for a once-weekly oral YEZTUGO formulation for HIV pre-exposure prophylaxis.

[Gilead — sNDA acceptance and PDUFA date](https://www.gilead.com/news/news-details/2026/u-s--fda-accepts-gileads-application-for-investigational-once-weekly-oral-yeztugo-potentially-the-first-long-acting-pill-for-hiv-prevention)

### August 18, 2026 — FDA accepted the sNDA for review

FDA accepted Gilead's supplemental NDA for lenacapavir 300-mg tablets as a potential once-weekly oral HIV pre-exposure prophylaxis regimen.

[Gilead — FDA acceptance announcement](https://www.gilead.com/news/news-details/2026/u-s--fda-accepts-gileads-application-for-investigational-once-weekly-oral-yeztugo-potentially-the-first-long-acting-pill-for-hiv-prevention)

### August 18, 2026 — Lenacapavir's PrEP clinical profile supported the filing

Gilead cited lenacapavir's HIV-prevention efficacy across two clinical trials as support for the once-weekly oral formulation submission.

[Gilead — clinical evidence supporting the sNDA](https://www.gilead.com/news/news-details/2026/u-s--fda-accepts-gileads-application-for-investigational-once-weekly-oral-yeztugo-potentially-the-first-long-acting-pill-for-hiv-prevention)

## 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