The PDUFA date of October 26, 2026 provides a clear catalyst timeline. Traders should monitor for any FDA advisory committee meeting announcements and potential competitor developments (e.g., Arrowhead, Vir Biotechnology). Approval would unlock a significant new revenue stream for GSK's vaccines/specialty portfolio.
Price Chart
Executive Summary
GSK announced FDA acceptance of its New Drug Application for bepirovirsen (chronic hepatitis B) with Priority Review and Breakthrough Therapy Designation, with a PDUFA date of October 26, 2026. The filing is supported by Phase III data showing statistically significant functional cure rates versus standard of care, addressing a large unmet need in a >250 million patient population. This is a positive regulatory milestone for a high-potential pipeline asset, though no financial terms or revenue estimates were disclosed.
Key Facts
- FDA accepted NDA for bepirovirsen with Priority Review and Breakthrough Therapy Designation
- PDUFA goal date set for October 26, 2026
- Phase III B-Well 1 and B-Well 2 trials showed statistically significant and clinically meaningful functional cure rates
- Chronic hepatitis B affects >250 million people globally; current functional cure rates ~1%
- Bepirovirsen licensed from Ionis Pharmaceuticals; not yet approved anywhere
- Breakthrough Therapy Designation added to prior Fast Track Designation (Feb 2024)
Financial Impact
No financial figures disclosed; potential multi-billion-dollar peak sales if approved given large addressable patient population and high unmet need
Risk Factors
- Regulatory risk: FDA could issue Complete Response Letter or require additional trials
- Commercial risk: pricing/reimbursement uncertainty and competition from other HBV curative approaches
- Clinical risk: long-term durability data still pending; safety profile in broader populations unknown
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001654954-26-003977 |
| Document: 0001654954-26-003977-index-headers.html | 0001654954-26-003977 |
| Document: 0001654954-26-003977-index.html | 0001654954-26-003977 |
| Document: 0001654954-26-003977.txt | 0001654954-26-003977 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jun 10, 2026 19w ago | 6-K | $25.12 $25.25 | ▲ +0.52% | ▼ −1.62% | $26.12 (+3.98%) |
Jun 9, 2026 19w ago | 6-K | $24.66 $25.50 | ▲ +3.41% | ▲ +1.60% | $26.12 (+5.92%) |
Jun 9, 2026 20w ago | 6-K | $24.66 $25.50 | ▲ +3.41% | ▲ +1.60% | $26.12 (+5.92%) |
Jun 1, 2026 21w ago | 6-K | $24.25 $24.66 | ▲ +1.69% | ▲ +4.44% | $26.12 (+7.71%) |
Jun 1, 2026 21w ago | 6-K | $24.25 $24.66 | ▲ +1.69% | ▲ +4.44% | $26.12 (+7.71%) |
May 28, 2026 21w ago | 6-K | $24.58 $24.66 | ▲ +0.33% | ▲ +0.01% | $26.12 (+6.27%) |
May 27, 2026 21w ago | 6-K | $25.57 $23.94 | ▼ −6.37% | ▼ −7.58% | $26.12 (+2.15%) |
May 26, 2026 22w ago | 6-K | $25.50 $24.25 | ▼ −4.90% | ▼ −5.99% | $26.12 (+2.43%) |
May 26, 2026 22w ago | 6-K | $25.50 $24.25 | ▼ −4.90% | ▼ −5.99% | $26.12 (+2.43%) |
May 22, 2026 22w ago | 6-K | $26.00 $24.25 | ▼ −6.73% | ▼ −8.39% | $26.12 (+0.46%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers