New clinical data on lecanemab to be presented at CTAD conference 2026

News provided by

BioArctic

Oct 30, 2026, 03:20 ET

STOCKHOLM, October 30, 2026 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present new clinical and real-world evidence on lecanemab (Leqembi®) at the Clinical Trials on Alzheimer's Disease (CTAD) conference in Boston, November 16-19, 2026. The presentations will include five-year data from the Clarity AD study, as well as findings from the real-world LEADER study in diverse US clinical settings. In addition, BioArctic will present a poster on the binding profile of lecanemab.

New real-world LEADER data demonstrate how lecanemab is being used in clinical practice

During the conference, new analyses will be presented from the LEADER study on the use of lecanemab in early Alzheimer's disease three years after FDA approval. LEADER is a retrospective, multicenter study based on real-world clinical data from different types of treatment centers across the US.

Five-year Clarity AD data highlight long-term outcomes with lecanemab

A featured oral presentation will report findings through five years of lecanemab treatment in the Clarity AD study, including the core and long-term extension phases, providing one of the longest-term follow-up datasets reported to date for an approved anti-amyloid therapy in Alzheimer's disease.

Additional key oral presentations will examine:

- Real-world safety of lecanemab, including ARIA rates and safety profiles reported across multiple countries

- Lecanemab treatment and α-synuclein co-pathology in the Clarity AD CSF substudy

Eisai's CTAD 2026 poster presentations will include additional research on real-world treatment experience with lecanemab, including analyses of effectiveness, safety, treatment persistence and subcutaneous administration. Other posters will examine the effect of lecanemab on key biological processes involved in Alzheimer's disease, including protein changes in CSF, biomarker-based diagnosis, long-term treatment outcomes and disease biology across the Alzheimer's continuum.

Key symposium

Wednesday, November 18, 11:00-11:40 AM Eastern Time (ET)

Lecanemab Three Years Post-Approval: A Comprehensive Multicenter Retrospective Study (LEADER) in Diverse US Clinical Settings

- Real-World Lecanemab Utilization and Outcomes from Initiation Through Maintenance Therapy in Early Alzheimer's Disease: A Multicenter, Real-World, Retrospective Study (LEADER)

- Sex-Based Outcomes of Lecanemab in Early Alzheimer's Disease: A Multicenter, Real-World Retrospective Study (LEADER)

- At-Home Subcutaneous Lecanemab Administration: A Multicenter, Real-World, Retrospective Study (LEADER)

Lecanemab oral presentations

Lecanemab poster presentations

The information was released for public disclosure, through the agency of the contact person below, on October 30, 2026, at 08:00 am CET.

For further information, please contact: 

Oskar Bosson, Chief Investor Relations & Communications Officer

E-mail: [email protected]

Telephone: +46 704 107 180

Jenny Ljunggren, External Communications and Investor Relations Manager

E-mail: [email protected]

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 four countries.

Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease has been ongoing since July 2020. These individuals are clinically normal and have intermediate or elevated levels of amyloid in their brains. 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

BioArctic has a long-term collaboration with Eisai since 2005 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 in 2007, and the Development and Commercialization agreement for the antibody lecanemab back-up for Alzheimer's disease, which was signed in 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) â 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.

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