This section highlights FDA-related milestones and regulatory updates for drugs developed by Arbutus Biopharma (ABUS).
Over the past two years, Arbutus Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AB-101 and Imdusiran. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AB-101 FDA Regulatory Timeline and Events
AB-101 is a drug developed by Arbutus Biopharma for the following indication: Oral PD-L1 inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AB-101
- Announced Date:
- May 7, 2025
- Indication:
- Oral PD-L1 inhibitor
Announcement
Arbutus Biopharma Corporation announced the presentation of five posters, including one late-breaker, highlighting imdusiran, its RNAi therapeutic and AB-101, its oral PD-L1 inhibitor, at the European Association for the Study of the Liver (EASL) Congress 2025.
AI Summary
At the 2025 European Association for the Study of the Liver (EASL) Congress, Arbutus Biopharma Corporation presented five posters, including one late-breaker poster showcasing important new data. The late-breaker focused on imdusiran, an RNA interference (RNAi) therapeutic, used in combination with VTP-300 and low dose nivolumab. This study showed promising results, with several chronic hepatitis B patients achieving a functional cure, marked by significant reductions in hepatitis B surface antigen levels.
In addition, Arbutus presented pre-clinical and clinical data on AB-101, its oral PD-L1 inhibitor. Early findings from its Phase 1a/1b trial report that AB-101 is safe, well-tolerated, and achieves high receptor occupancy without causing liver dysfunction. These encouraging results support further clinical studies to confirm the potential of imdusiran and AB-101 in treating chronic hepatitis B.
Read Announcement- Drug:
- AB-101
- Announced Date:
- April 23, 2025
- Indication:
- Oral PD-L1 inhibitor
Announcement
Arbutus Biopharma Corporation announced that five abstracts, including one late-breaker, have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7 - 10, 2025 in Amsterdam, Netherlands.
AI Summary
Arbutus Biopharma Corporation announced that five abstracts, including one late-breaker, have been accepted for poster presentations at the upcoming European Association for the Study of the Liver (EASL) Congress 2025. The event will take place between May 7 and 10, 2025, in Amsterdam, Netherlands, where the posters will be featured in the Viral Hepatitis B and D session. The abstracts highlight new therapies under evaluation for chronic hepatitis B, including results from trials combining imdusiran with pegylated interferon alfa-2a and nucleos(t)ide analogue therapy, as well as studies showcasing the profiles of a novel PD-L1 inhibitor, AB-101.
This acceptance at a major European conference underscores Arbutus’ commitment to advancing research in viral hepatitis and presents potential insights into treatments that could lead to a functional cure for patients with chronic hepatitis B.
Read Announcement- Drug:
- AB-101
- Announced Date:
- March 24, 2025
- Indication:
- Oral PD-L1 inhibitor
Announcement
Artiva Biotherapeutics, announced Recent Business Highlightsnc.
AI Summary
Artiva Biotherapeutics recently highlighted key business updates in its press release. The company showcased significant progress in its AlloNK® program for autoimmune diseases. Initial data from their autoimmune trial are expected in the first half of 2025, while updated clinical data from the Phase 1/2 NHL trial combining AlloNK® with rituximab will be presented at a medical conference later in 2025. These data point to deep B-cell depletion and durable responses with the treatment regimen suitable for outpatient administration.
Additionally, Artiva strengthened its leadership team by appointing experts in cell therapy and autoimmunity, including a new independent board member, Dr. Dan Baker. With a robust cash position of $185.4 million at the end of 2024, the company’s finances are expected to support operations through at least the end of 2026 as it advances its cell therapy pipeline.
Read Announcement
Imdusiran FDA Regulatory Events
Imdusiran is a drug developed by Arbutus Biopharma for the following indication: For chronic hepatitis B virus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Imdusiran
- Announced Date:
- January 13, 2025
- Indication:
- For chronic hepatitis B virus
Announcement
Arbutus Biopharma announced its 2025 corporate objectives and provided a financial update.
AI Summary
Arbutus Biopharma announced its 2025 corporate objectives along with a financial update focused on advancing its efforts to cure chronic hepatitis B. Following promising data from an earlier Phase 2a trial using its RNAi therapeutic imdusiran combined with interferon and nucleos(t)ide analogue therapy, the company plans to initiate a placebo-controlled Phase 2b trial in the first half of 2025. This trial, pending regulatory approval, will enroll about 170 patients to further evaluate the treatment’s potential.
Financially, Arbutus is on solid ground with approximately $123 million in cash, cash equivalents, and marketable securities. The firm expects to lower its net cash burn to $47–$50 million in 2025—down from around $65 million in 2024—which, along with anticipated milestones, should fund its operations through early 2028.
Read Announcement
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