Overview
- Two pivotal B‑Well 1 and B‑Well 2 trials met their primary endpoints, delivering a statistically significant and clinically meaningful functional cure rate versus standard care.
- The studies enrolled more than 1,800 patients and showed an acceptable safety and tolerability profile consistent with earlier research.
- Full results will be submitted for scientific presentation and peer review, with regulatory filings planned worldwide in the first quarter of 2026.
- If approved, the antisense therapy could become the first finite six‑month option for chronic hepatitis B and serve as a backbone for future sequential regimens.
- Ionis licensed bepirovirsen to GSK in 2019 under a deal with up to $150 million in milestones and 10%–12% tiered royalties, as GSK targets peak sales above £2 billion and analysts describe the readout as de‑risking with modest share gains.