Arbutus Biopharma announced FDA Fast Track designation for imdusiran in treating chronic hepatitis B, facilitating development and review of this clinical-stage candidate.
Key takeaways
FDA granted Fast Track designation to imdusiran (AB-729) for chronic hepatitis B treatment on April 15, 2026.
Fast Track enables earlier FDA meetings, potential Accelerated Approval, Priority Review, or Rolling Review.
In Phase 2a trials, 8 patients achieved functional cure with imdusiran plus NA therapy and interferon or nivolumab.
6 of 8 functional cure patients sustained it over two years; 41 patients off NA therapy for ≥48 weeks.
2 additional patients achieved functional cure in long-term follow-up.
Imdusiran generally safe, well-tolerated with HBsAg and HBV DNA reductions.