regulatory
confidence high
sentiment positive
materiality 0.65
Arbutus receives FDA Fast Track designation for imdusiran in chronic hepatitis B
Arbutus Biopharma Corp
- FDA granted Fast Track designation for imdusiran, an investigational therapy for chronic hepatitis B.
- Imdusiran has achieved functional cure in 10 chronic HBV patients in clinical trials to date.
- Fast Track may enable Accelerated Approval, Priority Review, or Rolling Review of a BLA or NDA.
- CEO Lindsay Androski said designation validates imdusiran as an important drug candidate.