Note: GSK press release dated April 28, 2026: '26 October 2026 assigned by FDA as PDUFA date' and 'The FDA has assigned 26 October 2026 as the Prescription Drug User Fee Act (PDUFA) goal date.' FDA accepted the NDA for priority review and granted Breakthrough Therapy Designation, added to the Fast Track Designation granted February 2024. Bepirovirsen is an investigational antisense oligonucleotide licensed from Ionis Pharmaceuticals; supported by the Phase III B-Well 1 and B-Well 2 trials showing statistically significant functional cure rates. Primary SEC copy of the same release: https://www.sec.gov/Archives/edgar/data/1131399/000165495426003977/a1144c.htm (GSK plc Form 6-K, filed 2026-04-28). Partner Ionis independently reports the same date in its 8-K/10-Q filings of 2026-04-29 and 2026-07-29 ('PDUFA target action date of October 26, 2026').
Drug Information
- Drug Name
- Bepirovirsen (CT.gov)
- Application Type
- NDA
- FDA Designations
- Priority ReviewBreakthrough TherapyFast Track
- Indication
- Chronic hepatitis B (CHB) in adults
Filing Details
- Company
- GSK plc →
- Stock Ticker
- GSK
- SEC CIK
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-08-02. Report an issue