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Arbutus Biopharma (ABUS) FDA Events

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FDA Events for Arbutus Biopharma (ABUS)

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.

Arbutus Biopharma's Drugs in FDA Review

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.

Imdusiran - FDA Regulatory Timeline and 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.

Arbutus Biopharma FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Arbutus Biopharma (ABUS) has reported FDA regulatory activity for the following drugs: AB-101 and Imdusiran.

The most recent FDA-related event for Arbutus Biopharma occurred on May 7, 2025, involving AB-101. The update was categorized as "Poster Presentation," with the company reporting: "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."

Current therapies from Arbutus Biopharma in review with the FDA target conditions such as:

  • Oral PD-L1 inhibitor - AB-101
  • For chronic hepatitis B virus - Imdusiran

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ABUS) was last updated on 7/9/2025 by MarketBeat.com Staff
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