- The FDA has notified via verbal communication regarding a clinical hold on Arbutus Biopharma Corporation's ABUS AB-101 Investigational New Drug (IND) application.
- AB-101 is a novel, oral PD-L1 inhibitor designed to reawaken and boost the immune system of patients with chronic hepatitis B virus (cHBV).
- Also Read: US Court Favors Moderna In COVID-19 Vaccine Patent Infringement Case With Arbutus Biopharma.
- The FDA indicated they will provide an official Clinical Hold letter to Arbutus within 30 days.
- Based on this communication, the company no longer intends to report initial data from the single-ascending dose portion of the Phase 1 clinical trial in the second half of 2023.
- Price Action: ABUS shares are down 12.8% at $2.52 during the premarket session on the last check Tuesday.
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