First patient treated with Leqembi® (lecanemab) in Sweden

Leqembi reaches its first routine-use patient in Sweden via a private clinic after EU approval but without public reimbursement backing.

Rhea-AI Summary

BioArctic (BIOA B) reports that Leqembi (lecanemab) is now available at a private clinic in Sweden and that the first Swedish patient outside a clinical study has started treatment since EU approval in April 2025.

Leqembi is indicated in the EU for adults with early Alzheimer's disease (mild cognitive impairment or mild dementia due to AD) who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. The New Therapies Council (NT-rådet) issued a negative recommendation in April 2026 for public reimbursement, so treatment is currently offered privately at Executive Health in Stockholm. Eisai leads global development and commercialization, while BioArctic holds co-commercialization rights in the Nordic region.

Positive

• First Swedish patient treated with Leqembi outside a clinical study after EU approval
• Leqembi approved in 53 countries and under review in 6 more
• IV maintenance dosing every four weeks approved in nine countries and regions
• Subcutaneous Leqembi Iqlik approved in the US for early Alzheimer's disease
• Subcutaneous initiation treatment approved in China and Japan in September 2026

Negative

• Sweden’s New Therapies Council gave a negative recommendation for publicly funded use in April 2026

News Explained

BioArctic has no development costs for Leqembi in Alzheimer’s disease and is entitled to sales-milestone payments and royalties on global sales, while Eisai handles clinical development, regulatory applications and global commercialization.

Market Context

Before publication, the supplied B record showed a -1.48% prior-day move; the provided data containe...

Analysis

Before publication, the supplied B record showed a -1.48% prior-day move; the provided data contained no post-publication price observation for this Swedish treatment update.

Key Figures

First patient treated: First patient EU approval: April 2025 Public-funding recommendation: April 2026 +1 more

First patient treated

First patient

Leqembi treatment at a private clinic in Sweden outside a clinical study

EU approval

April 2025

Leqembi received EU approval

Public-funding recommendation

April 2026

NT-rådet gave a negative recommendation for publicly funded healthcare inclusion

Countries approved

53 countries

Leqembi approval status

Key Terms

mild cognitive impairment, apolipoprotein e ε4, monoclonal antibody, subcutaneous dosing

4 terms

mild cognitive impairment medical

"clinical diagnosis of mild cognitive impairment (MCI) and mild dementia"

Mild cognitive impairment (MCI) is a medical condition where a person experiences noticeable decline in memory or thinking that is greater than expected for their age but does not yet interfere significantly with daily life, like forgetting appointments more often while still managing basic tasks. For investors, MCI matters because it defines a target patient group, shapes the size and urgency of markets for diagnostics and treatments, and influences clinical trial design, regulatory pathways and potential revenue for companies developing related drugs or tests.

apolipoprotein e ε4 medical

"apolipoprotein E ε4 (ApoE ε4[1]) non-carriers or heterozygotes"

Apolipoprotein E ε4 is a specific version of a gene involved in how the body handles fats and clears brain waste; think of it as a genetic “flavor” that some people inherit. It matters to investors because carrying this version raises the risk of late‑onset Alzheimer’s and can influence who benefits from treatments, affect clinical trial design and success rates, and drive demand for diagnostics and therapies, which can alter market value for related companies.

monoclonal antibody medical

"a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

subcutaneous dosing medical

"approved for subcutaneous dosing with an autoinjector"

Subcutaneous dosing is giving a drug by injection into the fatty layer just beneath the skin instead of into a vein or muscle. For investors, this matters because this route often makes medicines easier to use at home, can reduce administration costs, improve patient adherence, and influence device and manufacturing needs, all of which affect a product’s market appeal and revenue potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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STOCKHOLM, Sept. 22, 2026 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) announced today that Leqembi is now available at a private clinic in Sweden and that the first patient has started treatment. This is the first time a patient in Sweden has been treated outside of a clinical study since Leqembi received EU approval in April 2025.

"I am very happy that we are now starting to help people diagnosed with early Alzheimer's disease in Sweden as well. There is a significant unmet need for new treatment options that slow the progression of Alzheimer's disease from its early stages and reduce the overall burden for patients affected by the disease, their care partners, healthcare providers and society," said Gunilla Osswald, CEO of BioArctic. "It is great to see that this innovation, based on Professor Lars Lannfelt's research at Uppsala University, is finally, after more than 20 years of research and development, beginning to help patients in Sweden, where it all started."

Leqembi was approved in the EU in April 2025 as the first therapy that targets an underlying cause of Alzheimer's disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4^[1]) non-carriers or heterozygotes with confirmed amyloid pathology.^[2]

Following the EU approval, Eisai and BioArctic have worked to enable patient access in Sweden. However, in April 2026, the New Therapies Council, NT-rådet, gave a negative recommendation for inclusion of Leqembi in the publicly funded health care system. Following NT-rådet's recommendation, Executive Health in Stockholm, where the first patient was treated today, has been working to offer treatment to patients with early Alzheimer's disease.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for regulatory approval and global commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai.

The information was released for public disclosure, through the agency of the contact person below, on September 22, 2026, at 4:10 pm CEST.

For further information, please contact: 
Oskar Bosson, VP Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 704 107 180

Jenny Ljunggren, External Communications and Investor Relations Manager
E-mail: jenny.ljunggren@bioarctic.com
Telephone: +46 76 013 86 08

About Leqembi® (lecanemab)
Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Leqembi is approved in 53 countries and is under regulatory review in 6 countries and regions. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in nine countries and regions, including the US, Japan, China and the United Kingdom, and applications have been filed in eleven countries and regions. In the US, Leqembi Iqlik® is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. Subcutaneous initiation treatment was approved in China and Japan in September 2026, and applications are under review in two countries.

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody lecanemab back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport therapies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

_{[1] Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).ii ARIA is a recognized important side effect with lecanemab that involves swelling and potential bleeding in the brain.
[2] European Medicines Agency Summary of Product Characteristics (SmPC)}

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First patient treated with Leqembi® (lecanemab) in Sweden

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SOURCE BioArctic

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What patient population is Leqembi approved to treat in the EU?

Leqembi is indicated for adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and who have confirmed amyloid pathology.

Why is Leqembi currently being given at a private clinic in Sweden?

In April 2026, the New Therapies Council (NT-rådet) issued a negative recommendation for including Leqembi in Sweden's publicly funded health care system. Following this, Executive Health in Stockholm prepared to offer Leqembi treatment privately to patients with early Alzheimer's disease.

Who is responsible for Leqembi’s development and commercialization and what are BioArctic’s rights?

Eisai is responsible for clinical development, regulatory applications and global commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and is entitled to sales milestone payments and royalties on global sales, without bearing development costs for Alzheimer's indications.

What ongoing clinical studies with lecanemab are highlighted in the announcement?

The AHEAD 3-45 Phase 3 study in preclinical Alzheimer's disease has been ongoing since July 2020 and was fully recruited in October 2024. In addition, the Tau NexGen study for dominantly inherited Alzheimer's disease, ongoing since January 2022, includes lecanemab as the backbone anti-amyloid therapy.

How is Leqembi administered and what maintenance options are approved?

Leqembi is administered intravenously, with an initial phase of dosing every two weeks for 18 months. Following this, IV maintenance dosing every four weeks is approved in nine countries and regions. In the US, Leqembi Iqlik allows subcutaneous dosing via autoinjector as both starting and maintenance treatment, and subcutaneous initiation treatment was approved in China and Japan in September 2026.