Biogen to Present New Data Across Alzheimer's Disease Portfolio at CTAD 2026

• Diranersen late-breaking symposium will feature 96-week long-term extension data and additional 76-week biomarker and clinical data from the Phase 2 CELIA study in early Alzheimer's disease
• Lecanemab presentations will highlight new long-term and real-world evidence, including initial five-year Clarity AD open-label extension data and three-year LEADER data, with new analyses exploring maintenance treatment and at-home subcutaneous administration
• Presentations across Biogen’s Alzheimer’s disease portfolio reflect its continued commitment to advancing innovation in Alzheimer’s disease, from long-term treatment outcomes and real-world evidence to investigational approaches targeting core disease pathologies, including amyloid and tau
  
  

CAMBRIDGE, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced it will present new data across its Alzheimer’s disease portfolio at the 19th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, taking place November 16–19, 2026, at the Boston Marriott Copley Place in Boston, Massachusetts. Presentations will include expanded data from the Phase 2 CELIA study evaluating diranersen, an investigational tau-targeting antisense oligonucleotide (ASO), and new analyses from studies of lecanemab (brand name: LEQEMBI^®).

"Biogen has a long-standing commitment to advancing innovation in Alzheimer's disease, from generating evidence that informs clinical practice to pursuing novel approaches that target core disease pathologies," said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “At CTAD, we look forward to sharing important updates across our portfolio, including additional long-term and real-world evidence for LEQEMBI and new data from the Phase 2 CELIA study evaluating diranersen.”

Featured Scientific Sessions and Presentations

Diranersen
Diranersen is an investigational ASO designed to target MAPT mRNA and reduce the production of all tau isoforms, lowering both intracellular and extracellular tau protein. At CTAD, Biogen will present clinical, biomarker and safety data that build on results previously reported in July 2026 and further characterize the clinical, biomarker and safety profile of diranersen in the Phase 2 CELIA study in early Alzheimer's disease.

• Late Breaking Symposium: Additional Biomarker and Clinical Findings from the Phase 2 CELIA Study of Diranersen in Early Alzheimer’s Disease: Late Breaking Symposium 1, Tuesday, November 17, 4:45–5:25 PM EST
  This symposium will feature three analyses from CELIA, including 96-week long-term extension efficacy and safety data, additional 76-week tau biomarker and amyloid PET data, and 76-week item analyses and select subgroup efficacy data. These data build on previously reported CELIA results and further characterize the clinical, biomarker and safety profile of diranersen in early Alzheimer's disease.
  
  

Lecanemab
Featured lecanemab sessions at CTAD will highlight continued real-world evidence generation and long-term outcomes data related to the treatment of early Alzheimer’s disease.

• Symposium 5: Featured Research Session: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse U.S. Clinical Settings
  Wednesday, November 18, 11:00–11:40 AM EST
  This session will feature new real-world evidence from the LEADER study, including findings on lecanemab utilization and outcomes from treatment initiation through maintenance therapy, sex-based outcomes, and experience with at-home subcutaneous lecanemab administration across diverse U.S. clinical settings.
  
  
• Oral Communication: Long-Term Outcomes with Lecanemab in Early Alzheimer’s Disease: Initial Findings Through 60-Months of Clarity AD Open-Label Extension
  Monday, November 16, 6:00 PM EST
  This oral presentation will report initial findings through five years of the Clarity AD open-label extension, including long-term clinical outcomes, disease progression and safety with continued lecanemab treatment in early Alzheimer's disease.
  
  

Selected Additional Oral and Poster Presentations
Additional oral and poster presentations at CTAD highlight Biogen’s ongoing efforts to advance Alzheimer’s disease diagnosis, treatment and care, including real-world experience with lecanemab, approaches to patient identification and testing, treatment outcomes, and analyses modeling the potential broader impact of slowing disease progression. For a complete list of presentations, please refer to the CTAD scientific program.

• Lecanemab Treatment in Real-World Settings Across Multiple Countries: A Meta-Analysis on ARIA Rates and Safety Profiles in Clinical Practice
  Tuesday, November 17, 2:05–2:20 PM EST
  
  
• Lecanemab Treatment and α-Synuclein Co-Pathology in the Clarity AD CSF Substudy
  Thursday, November 19, 1:35–1:50 PM EST
  
  
• US Real-World Patterns of Amyloid Testing and Anti-Amyloid Therapy Initiation in Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI)
  Poster Session
  
  
• Baseline Radiologic Predictors of ARIA-E and ARIA-H: A Quantitative AI-Supported MRI Analysis of a US Real-World Cohort
  Poster Session
  
  
• A Prospective, Observational, Fully Decentralized Global Study to Identify Individuals for Alzheimer’s Disease Clinical Trials Using Digital Cognitive Assessments and Blood-Based Biomarkers
  Poster Session
  
  

About diranersen (BIIB080)
Diranersen (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 associated with neurodegeneration and cognitive decline.

Diranersen is being investigated as a potential treatment for early Alzheimer’s disease. In 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to diranersen for the treatment of 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 diranersen. Diranersen was discovered by Ionis.

About the CELIA Study
CELIA is a global Phase 2 randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy, safety and tolerability of diranersen in individuals with early Alzheimer’s disease. The study enrolled 416 participants with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia. All participants enrolled in CELIA had not previously received anti-amyloid therapy.

The study evaluated three doses of diranersen administered intrathecally over an 18-month placebo-controlled treatment period: 60 mg every six months, 115 mg every six months, and 115 mg every three months.

The primary endpoint of CELIA was assessment of dose response for change from baseline on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at Week 76. Secondary and exploratory endpoints included additional clinical, biomarker and imaging measures, including cerebrospinal fluid tau biomarkers and tau positron emission tomography (PET). Additional information on the CELIA study design is available in the ClinicalTrials.gov listing for the CELIA study.

An ongoing long-term extension (LTE) study is continuing to evaluate the long-term safety, tolerability and durability of diranersen in early Alzheimer’s disease.

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

Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, 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 was approved in 9 countries including the U.S., China, the UK, and others, and applications have been filed in 11 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing (360 mg) with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the U.S. in July 2026 and China in September 2026, and applications are under review in 2 countries.

Eisai and Biogen have been collaborating on the joint development and commercialization of Alzheimer’s disease 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.

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.

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This news release contains forward-looking statements, including, among others, relating to: the potential benefits, efficacy and safety of diranersen (BIIB080) and lecanemab (LEQEMBI); the potential to advance care and improve outcomes for, and address unmet needs of, patients with Alzheimer’s disease; potential regulatory discussions, submissions, decisions and approvals and the timing thereof; the anticipated benefits, risks and potential of our collaboration arrangements; the potential of our commercial business and pipeline programs, including Biogen’s research programs for Alzheimer’s disease; 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,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or 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.

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