# Bepirovirsen PDUFA Event: Chronic hepatitis B

Canonical URL: https://biopharmsignal.com/pdufa-calendar/GSK/bepirovirsen-chronic-hepatitis-b

Ticker: GSK

Company: GSK plc

Event date: 2026-10-26

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned an October 26, 2026 PDUFA goal date to the bepirovirsen NDA.

## Event Timeline

### October 26, 2026 — FDA decision expected

FDA assigned an October 26, 2026 PDUFA goal date to the bepirovirsen NDA.

[GSK — NDA acceptance and PDUFA date](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/)

### May 28, 2026 — Detailed Phase 3 B-Well results were reported

Across B-Well 1 and B-Well 2, 19% of qualifying participants achieved functional cure at week 72 with bepirovirsen plus standard of care versus 0% with placebo plus standard of care.

[GSK — Detailed B-Well 1 and B-Well 2 results](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-achieves-unprecedented-functional-cure-rates-with-potential-to-redefine-treatment-for-chronic-hepatitis-b/)

### April 28, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the application, granted Breakthrough Therapy designation and established the October goal date.

[GSK — NDA acceptance and regulatory designations](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/)

### January 7, 2026 — Both Phase 3 B-Well trials met their primary endpoints

Bepirovirsen plus standard of care produced statistically significant and clinically meaningful functional-cure rates versus standard of care alone in B-Well 1 and B-Well 2.

[GSK — Positive topline B-Well results](https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-b-well-1-and-b-well-2-phase-iii-trials-for-bepirovirsen-a-potential-first-in-class-treatment-for-chronic-hepatitis-b/)

### February 12, 2024 — FDA granted Fast Track designation

FDA granted Fast Track designation based on the potential to address an unmet need in chronic hepatitis B.

[GSK — Fast Track designation](https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b/)

### December 7, 2022 — Phase 3 B-Well 1 study started

B-Well 1 began evaluating bepirovirsen in nucleos(t)ide analogue-treated adults with chronic hepatitis B.

[ClinicalTrials.gov — B-Well 1 study record (NCT05630807)](https://clinicaltrials.gov/study/NCT05630807)

### December 6, 2022 — Phase 3 B-Well 2 study started

B-Well 2 began evaluating bepirovirsen in adults with chronic hepatitis B who were not receiving nucleos(t)ide analogue therapy.

[ClinicalTrials.gov — B-Well 2 study record (NCT05630820)](https://clinicaltrials.gov/study/NCT05630820)

## Regulatory Designations

- Priority Review FDA: [GSK — NDA acceptance and Priority Review](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/)

- Breakthrough Therapy FDA: [GSK — Breakthrough Therapy designation](https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/)

- Fast Track FDA: [GSK — Fast Track designation](https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b/)

## Related Pages

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

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

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

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