Biogen to Highlight Breadth of Alzheimer’s Disease Portfolio at AAIC 2026, Including Phase 2 CELIA Data for Diranersen

• Diranersen presentation will feature Phase 2 CELIA data in early Alzheimer’s disease, including clinical, biomarker and safety results for Biogen’s investigational tau-targeting ASO, following topline results announced in May 2026
• Lecanemab presentations will highlight emerging data on subcutaneous administration and real-world use, including practical treatment considerations, at-home administration, three-year LEADER data, maintenance dosing and patient experience
• Advances across Biogen’s Alzheimer’s disease portfolio underscore its leadership and continued commitment to innovation in Alzheimer’s care, spanning treatment delivery, real-world evidence and approaches targeting core pathologies, including amyloid and tau
  

CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced it will present new data across its Alzheimer’s disease portfolio at the Alzheimer’s Association International Conference (AAIC) 2026, taking place July 12-15 in London, UK. Presentations will include data from the Phase 2 CELIA study evaluating diranersen, an investigational tau-targeting antisense oligonucleotide (ASO), and new analyses from studies of LEQEMBI^® (lecanemab).

“Biogen remains committed to advancing innovation across Alzheimer’s care, from treatment delivery and real-world evidence generation to continued progress in addressing core pathologies, including amyloid and tau. Tau has long remained one of the most important targets in Alzheimer’s disease, and the Phase 2 CELIA topline results for diranersen reinforce the potential of tau reduction as a therapeutic approach in early Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Executive Vice President and Head of Development at Biogen. “We look forward to presenting initial data from this pioneering study as well as new data on lecanemab on the global stage at AAIC.”

Featured Scientific Sessions and Presentations

Diranersen
Diranersen is an investigational ASO that targets MAPT RNA to reduce tau production at its source, a differentiated approach to addressing abnormal tau both inside and outside neurons. At AAIC, Biogen will present clinical, biomarker and safety data that build on the May 2026 topline announcement and further characterize diranersen as the program advances toward Phase 3 development.

• Topline Results from CELIA: A Phase 2 Study to Evaluate the Tau-Targeting ASO Diranersen (BIIB080) in Patients with Early Alzheimer’s Disease
  Developing Topics Session: Developing Topics in Phase 2 Clinical Trials,
  Tuesday, July 14, 2:00–3:30 PM BST
  
  

This presentation will feature data from CELIA, an 18-month Phase 2 study evaluating diranersen, Biogen’s investigational tau-targeting ASO, in patients with early Alzheimer’s disease. The presentation will include initial clinical, biomarker and safety results from the study.

Lecanemab
Featured lecanemab sessions at AAIC will highlight continued progress in the treatment landscape for early Alzheimer’s disease, with data spanning subcutaneous administration, including at-home use, practical treatment considerations, and three-year real-world evidence from the multicenter LEADER study.

• Developing Topics Session: Lecanemab Subcutaneous Formulation in Early Alzheimer's Disease: Emerging Clinical Evidence and Practical Use Considerations
  Sunday, July 12, 4:15–5:45 PM BST
  
  

This session will feature presentations on the emerging clinical evidence, safety profile, practical use considerations and real-world patient experience with subcutaneous lecanemab administration in early Alzheimer’s disease.

• Featured Research Session: Lecanemab Three Years Post-Approval: A Comprehensive Multicenter, Real-World, Retrospective Study (LEADER) in Diverse U.S. Clinical Settings
  Tuesday, July 14, 4:15–5:45 PM BST
  
  

This session will feature new real-world evidence from the LEADER study, including findings on lecanemab use and outcomes across diverse U.S. clinical settings, once-monthly maintenance dosing, patient pathways and physician and perceived patient satisfaction with maintenance therapy.

Selected Additional Oral and Poster Presentations
The following selected presentations highlight additional areas of Alzheimer’s disease research being presented at AAIC, including lecanemab-related data. For a complete list of presentations, please refer to the AAIC scientific program.

• Real-world Insights into Clinician Involvement and Testing Approaches for Mild Cognitive Impairment and Alzheimer’s
  Monday, July 13, 7:30 AM–4:15 PM BST

• Continued or Time-limited Treatment Benefits of Anti-amyloid Monoclonal Antibodies in Early Alzheimer’s Disease
  Monday, July 13, 7:30 AM–4:15 PM BST
  
• Lecanemab Treatment for Alzheimer’s Disease in Real-World Clinical Practice: A Multicenter, Surveillance Safety Study from the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) Registry
  Tuesday, July 14, 9:00–10:30 AM BST
  
• Impact of Biomarker Modalities in the Diagnostic Evaluation of Patients with Suspected Alzheimer’s Disease: A US Retrospective Study
  Wednesday, July 15, 7:30 AM–4:15 PM BST

• Estimating the Economic Impact of Delayed Alzheimer’s Disease Progression with Lecanemab
  Wednesday, July 15, 7:30 AM–4:15 PM BST
  
  

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 2026 program and visit the Biogen AAIC booth.

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. Unlike many investigational approaches that have focused on targeting extracellular tau, diranersen is designed to reduce both intracellular and extracellular tau.

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 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 indicated in the U.S. for the treatment of Alzheimer’s disease and treatment 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. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. 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 treatment phase with intravenous dosing every two weeks for 18 months, intravenous maintenance dosing every four weeks has been approved in 7 countries, including the U.S., China and the UK, with applications filed in additional countries and regions. In the U.S., FDA approved LEQEMBI IQLIK™ for once-weekly subcutaneous maintenance dosing in August 2025. A supplemental Biologics License Application for LEQEMBI IQLIK as a once-weekly subcutaneous starting dose is currently under FDA Priority Review, with a Prescription Drug User Fee Act action date of August 24, 2026.

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.

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, 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 Alzheimer’s disease portfolio; 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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