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
Date & time (Eastern Time, ET) | Title and abstract number |
November 16 6:00–6:15 PM | Long-Term Outcomes with Lecanemab in Early Alzheimer's Disease: Initial Findings Through 60-Months of Clarity AD Open-Label Extension (OC6) |
November 17 10:20–10:35 AM | Sex Differences in Plasma p-tau217, Amyloid-β, and Tau-PET in Cognitively Unimpaired Adults from the AHEAD International Screening Cohort (OC10) |
November 17 2:05–2:20 PM | Lecanemab Treatment in Real-World Settings Across Multiple Countries: A Meta-Analysis on ARIA Rates and Safety Profiles in Clinical Practice (OC13) |
November 18 4:00–4:15 PM | Beyond Amyloid and Tau: Hippocampal Volume and Cognitive Performance in the AHEAD 3-45 Study Screening Cohort (OC36) |
November 19 1:35–1:50 PM | Lecanemab Treatment and α-Synuclein Co-Pathology in the Clarity AD CSF Substudy (OC50) |
Lecanemab poster presentations
Date | Title and abstract number |
November 16–17 | Continuous vs. Finite Dosing Until Amyloid Plaque Clearance in Early Alzheimer's Disease: A Horizontal Matching Analysis of Long-Term Clinical Trajectories for Lecanemab and Donanemab (P001) |
November 16–17 | Updated Projections Confirm Long-Term Benefits of Continuous Lecanemab: 10 Years of Treatment Could Delay Moderate Disease (P002) |
November 16–17 | Beyond Amyloid Clearance: CSF Proteomics Reveals Proteome-Wide CNS Remodeling Following Lecanemab Treatment (P007) |
November 16–17 | Time Savings and Patient Preference for Subcutaneous Injection Versus Intravenous Infusion of Lecanemab (P149) |
November 16–17 | Updated Results from a Post-Marketing Observational Study of Lecanemab in Japan (P153) |
November 18 | Estimating the Durability of Residual Effects on Biomarkers After Discontinuation of Lecanemab (P319) |
November 18 | Binding Profile of Lecanemab in Brain of Patients with Early Alzheimer's Disease (P350) |
November 19 | Disaggregating Asian Populations in a Global Preclinical Alzheimer's Disease Trial: Recruitment, Screening and Randomization in the AHEAD 3-45 Study (P363) |
November 19 | Lecanemab Treatment in a New England Alzheimer's Disease Center: Real-World Outcomes from a Single-Center, Retrospective Case Series (P406) |
November 19 | Real-World Effectiveness, Safety, and Patient Experience of Lecanemab in the United States: A Systematic Literature Review (P407) |
November 19 | Real-World Patient-Reported Outcomes with Subcutaneous Lecanemab Treatment in Early Alzheimer's Disease in the US: A Case Series (P413) |
November 19 | Real-World Long-Term Persistence and Early Subcutaneous Maintenance Utilization of Lecanemab in the United States (P414) |
November 19 | A Retrospective, Case Series Analysis of Lecanemab Treatment in Individuals with Early Alzheimer's at a Colorado Neurological Clinic (P417) |
November 19 | Real-World Lecanemab Treatment in Early Alzheimer's Disease: A Retrospective Case Series from a Geriatric Medicine Clinical Practice (P418) |
November 19 | Patient Outcomes and Real-World Treatment Review and Assessment of Infusion Therapies with Lecanemab (P491) |
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: 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 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) – 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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New clinical data on lecanemab to be presented at CTAD conference 2026 |
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