6-KThe Wire
GSK plc files 6-K
Filed Apr 28, 2026 · 2mo ago · Accession 0001654954-26-003977
Plain English
GSK plc announced that the US FDA has accepted for priority review its New Drug Application (NDA) for bepirovirsen, an investigational treatment for chronic hepatitis B, and has granted it Breakthrough Therapy Designation. The FDA has assigned October 26, 2026, as the PDUFA goal date for this application.
Filing details
- Company
- GSK plc
- Ticker
- GSK
- CIK
- 1131399
- Form type
- 6-K
- Filing date
- Apr 28, 2026
- Report date
- Apr 28, 2026
- Document
- a1144c.htm
- Size
- 45 KB