Ionis partner GSK announces bepirovirsen accepted for Priority Review and granted Breakthrough Therapy Designation by U.S. FDA as a potential first-in-class medicine for chronic hepatitis B
Partner GSK announced that the FDA accepted the NDA for bepirovirsen for Priority Review and granted it Breakthrough Therapy designation, setting a PDUFA target action date of October 26, 2026. The submission is supported by Phase 3 B-Well trials showing statistically significant and clinically meaningful functional cure rates, positioning bepirovirsen as a potential first-in-class medicine for chronic hepatitis B.
Key figures
- Drug Name
- bepirovirsen
- Phase Of Trial
- Phase 3
- Pdufa date
- October 26, 2026
- Royalty rate
- 10-12%
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