Bepirovirsen Phase 3 achieves 19% functional cure rate in chronic hepatitis B; Q3 2026 FDA decision expected

IONIS PHARMACEUTICALS INC

19% functional cure rate (233/1,220) vs 0% placebo (p<0.001) in overall population (HBsAg ≤3000 IU/mL).
26% functional cure rate in patients with ≤1000 IU/mL HBsAg, representing ~45% of diagnosed CHB cases globally.
49% of bepirovirsen recipients achieved qHBsAg ≤100 IU/mL one year post-treatment in exploratory analysis.
Bepirovirsen under priority FDA review (Breakthrough/Fast Track); first regulatory decisions anticipated in Q3 2026.
Ionis eligible for tiered royalties of 10-12% on net sales plus milestones under 2019 GSK license.

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