BioArctic advances exidavnemab phase 2a cohorts after safety review

Swedish biopharmaceutical company BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) has initiated higher-dose cohorts in its ongoing Phase 2a trial of exidavnemab, a monoclonal antibody targeting synucleinopathies such as Parkinson’s disease and Multiple System Atrophy (MSA). The decision follows a favorable interim safety analysis in the EXIST (EXIdavnemab Synucleinopathy Trial), which demonstrated tolerability of a lower dose administered in Parkinson’s patients.

With this milestone, BioArctic will expand the trial to assess higher doses in Parkinson’s and introduce a new cohort for MSA, furthering its ambition to develop disease-modifying therapies for progressive neurodegenerative conditions. The drug candidate has also been granted orphan drug designation in the United States and received a positive opinion from the European Medicines Agency for MSA, streamlining its regulatory pathway and commercial prospects in niche neurological indications.

What is the purpose of the EXIST trial and how is it structured?

The EXIST study, launched in 2024, is a double-blind, randomized, placebo-controlled Phase 2a clinical trial assessing the safety, tolerability, and pharmacokinetic profile of exidavnemab. The study also integrates exploratory biomarker analysis from blood plasma and cerebrospinal fluid, as well as digital monitoring tools to evaluate neurological decline.

The first cohort assessed a lower dose in Parkinson’s disease patients, producing a clean safety signal. This outcome has led BioArctic to initiate two further cohorts—a higher-dose evaluation in Parkinson’s and a new dose-escalation arm in MSA patients. The results will lay the groundwork for a potential Phase 2b or proof-of-concept trial focused on clinical efficacy.

How exidavnemab works: BioArctic’s approach to targeting alpha-synuclein

Exidavnemab is a monoclonal antibody engineered to selectively bind toxic aggregates of alpha-synuclein, a misfolded protein that accumulates in the brains of patients with Parkinson’s disease and MSA. Importantly, the antibody spares physiological forms of alpha-synuclein, addressing a key limitation in prior candidates that failed due to off-target effects.

The drug builds on BioArctic’s proprietary antibody platform, the same foundation behind Leqembi (lecanemab), the world’s first approved treatment that slows cognitive decline in early Alzheimer’s disease. Developed in partnership with Eisai, Leqembi has generated significant credibility for BioArctic’s technology, which targets misfolded proteins implicated in neurodegeneration.

What orphan drug status means for exidavnemab in the U.S. and EU

Exidavnemab has received orphan drug designation from the U.S. Food and Drug Administration and a favorable opinion for orphan medicinal product designation from the European Medicines Agency, both for the treatment of Multiple System Atrophy. These designations grant up to 10 years of market exclusivity, reduced regulatory fees, and the potential for priority guidance from regulators.

The designations validate exidavnemab’s potential in a space with high unmet medical need. MSA, in particular, is a rapidly progressing disorder with no approved disease-modifying therapies, making it an attractive niche for accelerated development and commercial penetration.

How BioArctic’s 2024 financial results position it for pipeline growth

In its FY2024 results, BioArctic reported full-year revenue of SEK 257.35 million, a decline from SEK 616 million in FY2023, largely due to timing of milestone payments related to Leqembi. However, fourth-quarter 2024 revenue increased to SEK 101.24 million from SEK 11.02 million in the prior year’s quarter, driven by royalty income from Leqembi’s global expansion.

The Swedish biotech firm posted a net loss of SEK 177.08 million for FY2024, reversing from a net profit of SEK 229.25 million in FY2023. Increased R&D spending on exidavnemab and pipeline candidates explains the temporary loss. Still, BioArctic maintains a strong cash position and has reiterated guidance for a return to profitability in 2025, supported by Leqembi royalties and an ongoing licensing collaboration with Bristol Myers Squibb.

What BioArctic revealed about its strategy at the 2025 Capital Markets Day

At its June 2, 2025, Capital Markets Day, BioArctic executives outlined their long-term roadmap to become a top-tier European neuroscience firm. Key goals include expanding BrainTransporter-enabled drug programs, exploring new indications such as ALS and enzyme deficiency disorders, and broadening royalty income streams.

The company emphasized plans to balance innovation with shareholder returns. Management reaffirmed a commitment to dividends beginning in 2025, contingent on profitability, and underlined its intention to prioritize capital-efficient development of late-stage candidates like exidavnemab.

How BioArctic shares have responded in 2025

BioArctic’s B-share (BIOA B: STO) closed at SEK 201.60 on June 12, 2025, reflecting a 46% rebound from its 52-week low of SEK 137.70. Despite this recovery, the stock remains 26% below its 52-week high of SEK 271.40, presenting potential upside if key clinical milestones are met.

Trading volumes remain healthy, and technical indicators from MarketScreener and Investing.com currently rate the stock a “Strong Buy.” Analysts view the stock’s consolidation in the SEK 200–210 range as a base-building phase ahead of major trial catalysts.

What analysts are saying about BioArctic’s stock in 2025

Five equity analysts covering BioArctic maintain “Buy” recommendations, with target prices ranging from SEK 237 (Goldman Sachs) to SEK 350 (RBC), averaging SEK 289–308. This suggests an upside of 40–52% from current levels.

Valuation models such as discounted cash flow and intrinsic fair value from Simply Wall St show the stock trades at a significant discount, with estimates suggesting a 50–60% undervaluation relative to long-term earnings and pipeline potential.

How institutional and retail investors view BioArctic in 2025

Institutional ownership remains stable, with key stakeholders including Nordea Nordic Small Cap and Lannebo Sverige Plus holding meaningful positions. No major divestments have been disclosed in 2025, reinforcing confidence in BioArctic’s strategic execution.

Retail investor sentiment has also turned positive, especially across Nordic investor forums and biotech-focused groups. Discussions increasingly point to exidavnemab as BioArctic’s next high-value inflection point after Leqembi.

What investors can expect in the second half of 2025

Key catalysts for BioArctic in H2 2025 include biomarker and pharmacokinetic data from the higher-dose cohorts of the EXIST trial. These results are expected by Q4 2025 and will help determine whether the company proceeds to a Phase 2b proof-of-concept trial in 2026.

Additionally, broader commercialization of Leqembi in Europe, South Korea, and select LATAM markets is expected to drive revenue growth. The company is also scheduled to report Q2 earnings in late August, which may include additional updates on licensing and R&D partnerships.

Is BioArctic stock a buy after exidavnemab’s safety milestone?

Given exidavnemab’s positive safety validation, dual orphan designations, expanding clinical strategy, and improving financial outlook, BioArctic represents a compelling medium-term opportunity in the European biotech space.

For new investors, the current consolidation near SEK 200–210 offers an attractive entry range, while existing shareholders are likely to benefit from upcoming trial updates and further pipeline de-risking. A technical stop-loss around SEK 180 may be appropriate given sector volatility. More cautious investors may prefer to wait for Q4 biomarker data before initiating new positions.