Arbutus Biopharma Corporation (NASDAQ:ABUS) shares climbed 6% on Wednesday after the company revealed it had received Fast Track designation from the U.S. Food and Drug Administration for imdusiran, its treatment candidate for chronic hepatitis B.
The FDA’s Fast Track program is designed to accelerate the development and review of therapies targeting serious conditions with unmet medical needs. Drugs granted this status may benefit from more frequent interactions with the regulator and could qualify for pathways such as Accelerated Approval, Priority Review or Rolling Review, provided certain criteria are met.
Arbutus said that imdusiran has delivered a functional cure in 10 patients with chronic hepatitis B in clinical trials so far, while enabling many others to remain off ongoing medication.
The Warminster, Pennsylvania-based company is a clinical-stage biopharmaceutical firm focused on developing treatments for infectious diseases.