ABUS Arbutus Biopharma

Arbutus Announces FDA Lifts Clinical Hold on AB-101 IND for Chronic HBV

The FDA removed the clinical hold on the IND for AB-101, an oral PD-L1 inhibitor. Arbutus may now engage in additional clinical development of AB-101 in the United States and is evaluating next steps. This removes a prior regulatory barrier following completion of the Phase 1a/1b trial showing tolerability and target engagement.

Arbutus: FDA grants Fast Track designation to imdusiran (AB-729)

FDA granted Fast Track designation to imdusiran for chronic hepatitis B in April 2026. Fast Track status enables earlier and more frequent FDA interactions and potential for rolling review, Accelerated Approval, or Priority Review. The designation is intended to expedite development and review of therapies addressing serious unmet medical need.

Arbutus: FDA grants Fast Track designation to imdusiran for chronic hepatitis B

The FDA has granted Fast Track designation to imdusiran for chronic hepatitis B. This designation facilitates development and expedites FDA review for therapies addressing serious conditions with unmet medical need.