New clinical and real-world evidence on Lecanemab to be presented at AAIC conference 2026

New clinical and real-world evidence on Lecanemab to be presented at AAIC conference 2026

STOCKHOLM, June 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 Alzheimer's Association International Conference (AAIC) in London, July 12-15, including data on its subcutaneous formulation, long-term use across diverse patient groups, maintenance dosing, and at-home administration.

BioArctic will also participate in the Plenary Session "Prevalence of Alzheimer's Disease Pathology in the Community," taking place on 14 July (11:00am to 12:15pm BST). In a presentation called "Outcomes of Clinical Progression for Clinical Trials of People with Neuronal Synucleinopathy with Cognitive Impairment", strategies for assessing clinical progression in people with cognitive impairment related to α-synuclein pathology will be discussed, primarily across Parkinson's disease (PD), Parkinson's disease dementia (PDD), and dementia with Lewy bodies (DLB).

Key oral lecanemab presentations at AAIC

• Subcutaneous treatment data: On Sunday, July 12, as part of the "Developing Topics Session: Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations" (4:15-5:45pm BST), emerging clinical evidence and practical use considerations for the subcutaneous formulation of lecanemab will be presented, including clinical trial and real-world patient experience.
• LEADER study – real-world evidence from US clinical practice: On Tuesday, July 14, as part of the "Featured Research Session: Lecanemab Three Years Post Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse US Clinical Settings"
  (4:15-5:45pm BST), data from the LEADER study evaluating real-world lecanemab use in diverse US clinical settings three years post-approval, will be presented. It will include results on maintenance dosing with IV treatment every four weeks and the first reported findings of at-home subcutaneous administration.  
• Preclinical Alzheimer's Disease: Presentations on the Phase 3 AHEAD 3-45 study in preclinical Alzheimer's Disease will highlight progress of the trial, including updates on participant retention and engagement.

Additional oral presentations

Poster presentations on lecanemab
Poster viewing time is set from 7:30am – 4:15pm BST on the date of presentation

Eisai-Sponsored Symposium 

Symposium is intended for HCPs only

The information was released for public disclosure, through the agency of the contact person below, on June 30, 2026, at 8am 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. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 8 countries, including the United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik™ is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, Eisai's supplemental Biologics License Application (sBLA) regarding a subcutaneous starting dose with Leqembi Iqlik was granted Priority Review by the US FDA. The sBLA has been assigned an extended PDUFA date of August 24, 2026. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review.

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 and is currently preparing for commercialization in the Nordics 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 antibodies 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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