Biogen to Highlight Scientific Progress Across Alzheimer’s Disease at the Alzheimer’s Association International Conference 2025

Rhea-AI Summary

Biogen (NASDAQ:BIIB) announced upcoming presentations at the 2025 Alzheimer's Association International Conference (AAIC) in Toronto from July 27-31. The company will present key data on LEQEMBI® (lecanemab), including 48-month results from the Clarity AD open-label extension and insights into a new subcutaneous formulation for maintenance dosing.

The presentations will also feature tau-related research, including baseline characteristics from the CELIA Phase 2 trial of BIIB080, an investigational antisense oligonucleotide therapy targeting tau. Additionally, Biogen will showcase real-world evidence, treatment comparisons, and host an educational program on tau in Alzheimer's disease through an interactive booth and e-learning resources.

• Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care
• Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice

CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI^® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau.

“At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer’s is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.”

Key Scientific Sessions and Presentations:

• Lecanemab Clarity AD OLE in Early AD: Initial Findings from 48-Month Analysis
  Wednesday, July 30, 8:00–8:45 AM ET
• Lecanemab Subcutaneous Formulation for Maintenance Dosing: The Potential of a New and Convenient Option for Ongoing Treatment in Early Alzheimer’s Disease
  Wednesday, July 30, 9:00–10:30 AM ET
• Patient, Care Partner, and Health Care Professional Opinion of the Lecanemab Autoinjector for Subcutaneous Delivery
  Sunday, July 27, 8:00–8:45 AM ET
• Lecanemab Two Years Post-Approval: Real-World Case Series and Patient Pathway Learnings
  Sunday, July 27, 9:00–10:30 AM ET
• Indirect Treatment Comparison of ARIA Outcomes for Lecanemab Compared to Donanemab Based on Reported Results
  Sunday, July 27, 4:14–5:45 PM ET
• Innovations in Tau Therapies and Biomarkers for Alzheimer’s Disease: Bridging Research and Clinical Practice
  Wednesday, July 30, 2:00–3:30 PM ET
• Baseline Characteristics from CELIA: A Phase 2 Study to Evaluate BIIB080 in Participants with Early Alzheimer’s Disease
  Monday, July 28, 7:30 AM–4:15 PM ET
  

Educational Program on Tau in Alzheimer’s Disease
At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer’s disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on KnowTau.com, building on the resources already available.

For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth.

About BIIB080
BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer’s disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer’s disease.

In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO).  BIIB080 was discovered by Ionis.

About LEQEMBI ^® (lecanemab)
LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023.

LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

We routinely post information that may be important to investors on our website at  www.biogen.com. Follow us on social media - Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

MEDIA CONTACT: Biogen Madeleine Shin + 1 781 464 3260 public.affairs@biogen.com

INVESTOR CONTACT: Biogen Tim Power +1 781 464 2442 IR@biogen.com

FAQ

When and where is Biogen presenting at AAIC 2025?

Biogen will present at the Alzheimer's Association International Conference (AAIC) from July 27-31, 2025 in Toronto, Canada.

What new LEQEMBI data will Biogen (BIIB) present at AAIC 2025?

Biogen will present 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing.

What is BIIB080 and what will Biogen present about it at AAIC 2025?

BIIB080 is an investigational antisense oligonucleotide (ASO) therapy targeting tau. Biogen will present baseline characteristics from the CELIA Phase 2 trial evaluating its efficacy, safety, and tolerability.

What educational resources will Biogen provide at AAIC 2025?

Biogen will host an interactive booth offering an immersive journey into tau's role in Alzheimer's disease and provide a new e-learning module on KnowTau.com.