BioArctic AB Advances Exidavnemab Phase 2a Study with Positive Safety Review

Stockholm, June 13, 2025 — BioArctic AB (publ) (NASDAQ Stockholm: BIOA B), a research-intensive biopharmaceutical company specializing in neurodegenerative diseases, announced today that the interim safety review of their clinical Phase 2a study, EXIST, has shown exidavnemab to be safe and well-tolerated. This positive outcome has led to the initiation of the next dose cohorts in the study.

The EXIST study is focused on evaluating exidavnemab, a drug candidate being developed for the treatment of Parkinson’s disease and Multiple System Atrophy (MSA). The initial cohort of the study assessed a lower dose of exidavnemab compared to a placebo in patients with Parkinson’s disease. The interim safety review confirmed that exidavnemab was safe and well-tolerated, paving the way for the initiation of two additional cohorts to evaluate higher doses of the drug in comparison with a placebo.

BioArctic AB, headquartered in Stockholm, Sweden, is known for its innovative approaches in developing disease-modifying treatments and diagnostics for neurodegenerative diseases. The company’s portfolio includes BAN2401, a humanized monoclonal antibody currently in Phase 2b clinical trials for Alzheimer’s disease, and other promising candidates like BAN0805 for Parkinson’s disease and SC0806 for spinal cord injuries.

The company has also received orphan drug designation in the US and a positive opinion for orphan designation in the EU for MSA, highlighting the potential impact of exidavnemab in treating these challenging conditions. Despite the early stage of the clinical trial and the absence of efficacy data, the successful safety review marks a significant milestone in the development of exidavnemab.

BioArctic AB continues to build on its scientific approach, similar to that of the approved drug Leqembi, and maintains collaborations with major pharmaceutical companies such as Eisai Co., Ltd. and AbbVie Inc. The company’s commitment to advancing treatments for neurodegenerative diseases remains steadfast as it progresses through the clinical development phases.

Fundamental Information:

  • Sector: Health Care
  • Industry: Biotechnology
  • Primary Exchange: Swedish Stock Exchange
  • Currency: SEK
  • Close Price (2025-05-29): 182.7 SEK
  • 52 Weeks High: 259.4 SEK (2025-02-19)
  • 52 Weeks Low: 137.7 SEK (2024-11-07)
  • Market Cap: 14,910,000,000 SEK
  • Price Earnings Ratio: 19.73

BioArctic AB’s progress with exidavnemab underscores its dedication to addressing unmet medical needs in neurodegenerative diseases, with a focus on safety and efficacy in its clinical trials.