Ionis partner GSK reports positive Phase 3 data for hepatitis B drug; FDA decision due Q3 2026

Filed May 28, 2026 · Period ending May 28, 2026 · ~1 min read

Key Changes

• high

  GSK's Phase 3 trials for bepirovirsen met primary endpoints with 19% functional cure rate vs 0% placebo in chronic hepatitis B patients—far exceeding current standard of care (<1% cure rate).

  Item 8.01 verify on EDGAR →
• high

  In patient subgroup representing 45% of global CHB cases, bepirovirsen achieved 26% functional cure rate. FDA decision expected Q3 2026; drug has Breakthrough and Fast Track designations.

  Item 8.01 verify on EDGAR →
• high

  Ionis eligible for additional regulatory and sales milestones plus 10-12% tiered royalties on net sales. Has already received upfront, license, and development milestone payments from GSK.

  Item 8.01 verify on EDGAR →