Arbutus says FDA lifted clinical hold on AB-101 IND application
Arbutus Biopharma announced that the U.S. Food and Drug Administration removed the clinical hold on the Investigational New Drug application for AB-101, its oral PD-L1 inhibitor for chronic hepatitis B. The company may now engage in additional clinical development of AB-101 in the United States and says it is evaluating next steps.
Key points
- FDA removed the clinical hold on the IND application for AB-101, announced October 22, 2026
- AB-101 completed a Phase 1a/1b trial, which the company says was generally well-tolerated
- Trial data showed high receptor occupancy in seven chronic HBV patients and hepatitis B surface antigen decline in two patients at the 30mg dose
The filing
Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 22, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.