BioArctic AB Advances Exidavnemab Development with Positive Safety Review

STOCKHOLM, June 13, 2025 — BioArctic AB (publ) (NASDAQ Stockholm: BIOA B), a leading biopharmaceutical company specializing in neurodegenerative diseases, has announced a significant milestone in the development of its drug candidate, exidavnemab. Following a positive interim safety review of the Phase 2a clinical study EXIST, the company will initiate the next cohorts to evaluate higher doses of exidavnemab in patients with Parkinson’s disease and Multiple System Atrophy (MSA).

The EXIST study, which initially assessed a lower dose of exidavnemab compared to a placebo in Parkinson’s disease patients, demonstrated that the drug candidate is safe and well-tolerated. This encouraging outcome has paved the way for the initiation of two additional cohorts to explore the efficacy and safety of higher doses of exidavnemab.

Exidavnemab is being developed as a potential treatment for Parkinson’s disease and MSA, leveraging a scientific approach similar to that of the approved drug Leqembi. The drug has already received orphan drug designation in the United States and a positive opinion for orphan designation in the European Union for MSA, underscoring its potential impact in these challenging therapeutic areas.

BioArctic’s commitment to advancing treatments for neurodegenerative diseases is further evidenced by its diverse pipeline, which includes BAN2401, a humanized monoclonal antibody in Phase 2b clinical trials for Alzheimer’s disease, and several other promising candidates targeting various aspects of neurodegeneration.

As BioArctic continues to build on its strategic collaborations with industry leaders such as Eisai Co., Ltd. and AbbVie Inc., the company remains focused on delivering innovative solutions to patients suffering from debilitating neurological conditions. While the early-stage clinical trial for exidavnemab has yet to provide efficacy data, the successful progression to higher dose cohorts marks a crucial step forward in its development journey.

Investors and stakeholders will be closely monitoring BioArctic’s progress as the company navigates the complex landscape of clinical development and regulatory approval. With a market capitalization of 14.91 billion SEK and a price-to-earnings ratio of 19.73, BioArctic’s strategic advancements in its pipeline could significantly influence its financial trajectory in the coming years.

As BioArctic moves forward with its clinical trials, the company’s dedication to innovation and collaboration positions it as a key player in the biotechnology sector, with the potential to make a meaningful impact on the lives of patients worldwide.