other material
confidence high
sentiment positive
materiality 0.80
Bepirovirsen Phase 3 positive: primary endpoint met, functional cure rates superior to SOC
IONIS PHARMACEUTICALS INC
- Over 1,800 patients enrolled in two Phase 3 studies (B-Well 1 & 2) across 29 countries.
- Bepirovirsen + SOC achieved statistically significant functional cure rates vs. SOC alone on all ranked endpoints.
- Ionis eligible for up to $150M in regulatory/sales milestones plus 10-12% tiered royalties.
- Global regulatory submissions planned from Q1 2026; potential first finite 6-month CHB therapy.
- Drug has Fast Track FDA, Breakthrough Therapy China, and SENKU Japan designations.