Arbutus sheds 18% after FDA clinical hold on antiviral

• Arbutus Biopharma (NASDAQ:ABUS) lost ~24% pre-market Tuesday after announcing that the FDA placed on clinical hold its Investigational New Drug (IND) application for AB-101, an oral PD-L1 inhibitor targeted at chronic infections due to the hepatitis B virus.
• The Warminster, Pennsylvania-based biotech said that the FDA notified its decision via verbal communication, and an official Clinical Hold letter is due within 30 days.
• In March, Arbutus (ABUS) announced plans to begin a Phase 1 clinical trial for AB-101 in H1 2023 for healthy subjects.
• Given the setback, the company no longer intends to report initial data from the single-ascending dose portion of the trial in H2 2023.

Read more on Arbutus and its patent disputes

• Pfizer, BioNTech dip as Arbutus charges violation of COVID vaccine patents
• Moderna wins appeals court ruling in Arbutus COVID vaccine patent dispute
• Moderna favored at Morgan Stanley on U.S. support for Arbutus patent case