News for BIIB Stock

Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer’s Disease to be Authorized in the European Union Biogen’s Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer’s Disease Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S. Biogen Announces Plans for New Global Headquarters and Innovation Hub in Kendall Square Cardurion Pharmaceuticals Appoints Karen Lewis as Chief People Officer Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease Biogen and Stoke Therapeutics Enter into Collaboration to Develop and Commercialize Zorevunersen for the Treatment of Dravet Syndrome, a Rare Genetic Epilepsy Associated with Refractory Seizures and Neurodevelopmental Impairments Biogen and Stoke Therapeutics Enter into Collaboration to Develop and Commercialize Zorevunersen for the Treatment of Dravet Syndrome, a Rare Genetic Epilepsy Associated with Refractory Seizures and Neurodevelopmental Impairments Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union Sage Therapeutics Board of Directors Initiates Review of Strategic Alternatives and Rejects Biogen’s Unsolicited Acquisition Proposal FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA FDA Accepts LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Sage Therapeutics Confirms Receipt of Unsolicited Nonbinding Acquisition Proposal from Biogen Cardurion Pharmaceuticals Appoints Charlotte Newman as Chief Business Officer "LEQEMBI®" (Lecanemab) Approved for the Treatment of Early Alzheimer's Disease in Mexico "LEQEMBI®" (Lecanemab) for the Treatment of Alzheimer's Disease Launched in South Korea Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease Eisai Completes Rolling Submission to US FDA for LEQEMBI® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status Eisai Presents Data on Benefits of Long-Term Administration of Dual-Acting Lecanemab at the 17th Clinical Trials for Alzheimer's Disease (CTAD) Conference Biogen and Neomorph Announce Multi-Target Research Collaboration to Discover and Develop Molecular Glue Degraders for Alzheimer’s, Rare, and Immunological Diseases Biogen Appoints Daniel Quirk, MD, as Chief Medical Officer Michael McDonnell, Executive Vice President and Chief Financial Officer to Retire in February 2025 Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024 Biogen to Present New Data at the Clinical Trials on Alzheimer's Disease (CTAD) 2024 Annual Conference Biogen Announces Late Breaker and New Data Presentations at American Society of Nephrology (ASN) Kidney Week 2024 Biogen Receives U.S. FDA Breakthrough Therapy Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients Talkiatry Expands Postpartum Depression Care Services to Close Gaps in Maternal Mental Healthcare New Higher Dose Nusinersen Efficacy and Safety Data Presented at World Muscle Society Congress, Highlight Potential to Maximize Benefit of Nusinersen in SMA UCB and Biogen Announce Positive Topline Results From Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus and are Initiating Second Phase 3 Study in 2024 Biogen Board Appoints Two New Independent Directors Biogen Announces Positive Topline Results from Study of Higher Dose Regimen of Nusinersen, Showing Significant Benefit in Treatment of SMA Leqembi® (lecanemab) Authorized for Early Alzheimer's Disease in Great Britain Alcyone Therapeutics Announces Continued Enrollment Approval from FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRx™ System for Administration of nusinersen New Clinical Data Demonstrates Three Years of Continuous Treatment with Dual-Acting LEQEMBI® (lecanemab-irmb) Continues to Significantly Benefit Early Alzheimer's Disease Patients Presented at The Alzheimer's Association International Conference (AAIC) 2024 Biogen, Beckman Coulter and Fujirebio to Collaborate on Blood-Based Biomarkers and Test for Tau Pathology in Alzheimer’s Disease Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union Sage Therapeutics and Biogen Announce Topline Results from Phase 2 KINETIC 2 Study of SAGE-324 (BIIB124) for the Treatment of Essential Tremor Biogen Completes Acquisition of Human Immunology Biosciences “LEQEMBI®” (Lecanemab) for the Treatment of Alzheimer’s Disease Launched in China TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®, Approved in the European Union FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Biogen and Delta Flight Products to Collaborate with Advocates and Patients to Inform the Future of Accessible Air Travel Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences Ionis and Biogen Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status Biogen Reports Progress on Corporate Responsibility Priorities Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA® Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA AbCellera to Collaborate with Biogen to Discover Therapeutic Antibodies for Neurological Conditions New Biomarker Data Add Further Evidence Supporting the Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs after Gene Therapy Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia Aptar Signs Enterprise Agreement with Biogen to Operate and Develop Digital Health Solutions Biogen to Realign Resources for Alzheimer's Disease Franchise Alcyone Therapeutics Announces First Patient Implanted in PIERRE IDE Clinical Study of the ThecaFlex DRx™ System for Administration of SPINRAZA® (nusinersen) Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S. Biogen Appoints Monish Patolawala to its Board of Directors EISAI PRESENTS NEW LEQEMBI® (LECANEMAB-IRMB) INVESTIGATIONAL SUBCUTANEOUS FORMULATION INTERIM STUDY RESULTS AND CLINICAL IMPROVEMENT DATA IN EARLIER STAGES OF EARLY ALZHEIMER'S DISEASE FROM ADDITIONAL ANALYSES OF CLARITY AD AT THE CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE New Data from Biogen’s Investigational Antisense Oligonucleotide (ASO) Targeting Tau Shows Promise for Potential New Generation of Treatments in Early Alzheimer’s Disease LEQEMBI® (lecanemab-irmb) NAMED ONE OF TIME's BEST INVENTIONS OF 2023 Biogen to Present New Data at the Clinical Trials on Alzheimer’s Disease (CTAD) 2023 Meeting FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA® Biogen Completes Acquisition of Reata Pharmaceuticals LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan Octave® Bioscience, Inc. Announces Real-World Study Using its Multimodal Precision Care Solution for Multiple Sclerosis Patient Management Biogen Appoints Jane Grogan as Head of Research FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder Biogen to Acquire Reata Pharmaceuticals Eisai Presents Latest Analysis of Lecanemab’s Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer’s Association International Conference (AAIC) 2023 FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease New Data at Cure SMA Highlight Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA® (nusinersen) Biogen Announces Changes to Its Board of Directors FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer's Disease Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS Biogen Appoints Adam Keeney as Head of Corporate Development Additional Detailed Analyses From Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting New Data Presented at AD/PD™ 2023 Show Biogen’s BIIB080 (MAPT ASO) Substantially Reduced Tau Protein Levels in Patients with Early-stage Alzheimer’s Disease Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection Biogen Appoints Chuck Triano as Head of Investor Relations Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for Zuranolone FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression Lecanemab Receives Priority Review Status in Japan Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency EISAI FILES MARKETING AUTHORIZATION APPLICATION FOR ANTI-AMYLOID-BETA PROTOFIBRIL ANTIBODY LECANEMAB FOR EARLY ALZHEIMER'S DISEASE IN JAPAN EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE IN EUROPE Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease Biogen Names Priya Singhal as Executive Vice President, Head of Development Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapies EISAI INITIATES BLA SUBMISSION OF DATA FOR LECANEMAB IN CHINA Biogen Reaches Agreement with Genentech to Receive Royalties on the Potential Commercialization of a Late-Stage Bispecific Antibody as Part of Anti-CD20 Collaboration FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab) Sage Therapeutics and Biogen Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS EISAI PRESENTS FULL RESULTS OF LECANEMAB PHASE 3 CONFIRMATORY CLARITY AD STUDY FOR EARLY ALZHEIMER'S DISEASE AT CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE ELEVEN EXPERTS FROM LEADING MEDICAL INSTITUTIONS AND EIGHT EXPERTS FROM EISAI* PUBLISH FULL RESULTS OF LECANEMAB PHASE 3 CONFIRMATORY CLARITY AD STUDY FOR EARLY ALZHEIMER'S DISEASE IN THE NEW ENGLAND JOURNAL OF MEDICINE Sage Therapeutics and Biogen to Host Investor Webcast on December 6, 2022 to Discuss Potential Commercialization Plans for Zuranolone Biogen Names Christopher Viehbacher President and Chief Executive Officer Biogen Data at ECTRIMS 2022 Highlight Innovation in Digital Health Focused on Advancing Treatment and Personalized Care of People Living with MS New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS Biogen Announces FDA’s 3-Month Extension of Review Period for the New Drug Application for Tofersen Sage Therapeutics and Biogen Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress GoodRx and Biogen Collaborate to Help Enhance Enrollment Experience for Providers Who Have Chosen to Start Multiple Sclerosis Patients on VUMERITY® Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab) LECANEMAB CONFIRMATORY PHASE 3 CLARITY AD STUDY MET PRIMARY ENDPOINT, SHOWING HIGHLY STATISTICALLY SIGNIFICANT REDUCTION OF CLINICAL DECLINE IN LARGE GLOBAL CLINICAL STUDY OF 1,795 PARTICIPANTS WITH EARLY ALZHEIMER'S DISEASE The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS Sage Therapeutics and Biogen Present New Analyses at Psych Congress Further Evaluating the Efficacy and Safety of Zuranolone The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus EISAI PRESENTS NEW FINDINGS ON LECANEMAB'S INVESTIGATIONAL SUBCUTANEOUS FORMULATION AND MODELING SIMULATION OF APOE4 GENOTYPE ON ARIA-E INCIDENCE AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2022 The New England Journal of Medicine Publishes Positive Phase 2 Data on Litifilimab (BIIB059) in Cutaneous Lupus Erythematosus FDA Accepts Biogen’s New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS THE U.S. FDA ACCEPTS AND GRANTS PRIORITY REVIEW FOR EISAI'S BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER'S DISEASE UNDER THE ACCELERATED APPROVAL PATHWAY Biogen and Happify Health Collaborate to Support Multiple Sclerosis Patients on Digital Platform European Patent Office Grants Patent Related to TECFIDERA® (Dimethyl Fumarate) New Data Presented at Cure SMA Reveal Residual Unmet Needs in Young SMA Patients Treated With Gene Therapy and Suggest Further Potential of Using SPINRAZA® (nusinersen) The Biogen Foundation and Community Lab Celebrates 20 Years of Serving our Communities Biogen and Alectos Therapeutics Announce License and Collaboration Agreement for AL01811, a Novel GBA2 Inhibitor for the Potential Treatment of Parkinson’s Disease Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate at the Annual European Congress of Rheumatology (EULAR 2022) New 12-Month Tofersen Data Presented at ENCALS Meeting Show Clinically Meaningful Benefit in People With SOD1-ALS Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints EISAI COMPLETES ROLLING SUBMISSION TO THE U.S. FDA FOR BIOLOGICS LICENSE APPLICATION OF LECANEMAB FOR EARLY ALZHEIMER'S DISEASE UNDER THE ACCELERATED APPROVAL PATHWAY Biogen and MedRhythms to Develop and Commercialize a Prescription Digital Therapeutic Targeting the Treatment of Gait Deficits in Multiple Sclerosis Scribe Therapeutics Expands Collaboration With Biogen to Second Target Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD) New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio and Emerging Research on Disease Progression Biogen Submits Final Protocol for ADUHELM® (aducanumab-avwa) Phase 4 ENVISION Trial to FDA Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis LATEST FINDINGS ON LECANEMAB - CLINICAL EFFICACY, ARIA RATES, BIOMARKERS RELATIONSHIP TO CLINICAL OUTCOMES AND DOSING REGIMENS - PRESENTED AT AD/PD™ 2022 ANNUAL MEETING Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments Biogen Announces New Updates Across its SMA Research Program at 2022 MDA Conference Biogen to Present New Research at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022) EISAI INITIATES SUBMISSION OF APPLICATION DATA UNDER THE PRIOR ASSESSMENT CONSULTATION SYSTEM IN JAPAN WITH THE AIM OF OBTAINING EARLY APPROVAL FOR INVESTIGATIONAL ANTI-AMYLOID BETA PROTOFIBRIL ANTIBODY LECANEMAB Sage Therapeutics and Biogen Announce the Phase 3 CORAL Study Met its Primary and Key Secondary Endpoints - Comparing Zuranolone 50 mg Co-initiated with Standard of Care Antidepressant vs. Standard of Care Co-initiated with Placebo in People with MDD Biogen and Xbrane Announce Commercialization and License Agreement for Proposed Biosimilar Referencing CIMZIA® (Certolizumab pegol) with the Potential to Treat Rheumatoid Arthritis Biogen Exercises Option to Participate in the Development and Commercialization of a Late-Stage Bispecific Antibody Biogen Announces Nancy Leaming and Brian Posner to Retire from Board of Directors Biogen Reaches Agreement with Samsung Biologics to Sell Equity Stake in Their Biosimilar Joint Venture for up to $2.3 billion Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM® Biogen Exercises Option with Ionis to Develop and Commercialize Investigational ASO for SMA Biogen Exercises Option with Ionis to Develop and Commercialize Investigational ASO for SMA INVESTIGATIONAL ALZHEIMER'S DISEASE THERAPY LECANEMAB GRANTED FDA FAST TRACK DESIGNATION Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data; Aducanumab Remains under Review Biogen Announces Reduced Price for ADUHELM® to Improve Access for Patients with Early Alzheimer’s Disease Update on Regulatory Submission for Aducanumab in the European Union Update on the Phase 4 Confirmatory Study of ADUHELM® Biogen and TheraPanacea Announce New Collaboration with the Potential to Advance Digital Health for Personalized Medicine in Neuroscience Sage Therapeutics and Biogen Announce New Analyses from the LANDSCAPE Clinical Development Program of Zuranolone in MDD Presented at the American College of Neuropsychopharmacology (ACNP) Congress Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD Update on Regulatory Review of Aducanumab in the European Union The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis Biogen Announces Alfred W. Sandrock, Jr. to Retire as Head of Research & Development Biogen Sets Industry Record with Recognition on Dow Jones Sustainability World Index for 9th Consecutive Year New Phase 3 Data Show Positive Correlation Between ADUHELM™ Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease Introduction of First-Of-A-Kind Plasma-Based Biomarker Screening To Facilitate Identification Of Subjects For Phase 3 Ahead 3-45 Trial Presented At Clinical Trials On Alzheimer's Disease (CTAD) Conference Eisai Presents New Analysis Of Lecanemab Clinical Efficacy Results From Phase 2b Study At Clinical Trials On Alzheimer's Disease (CTAD) Conference Eisai Presents Late-Breaker Updates On Lecanemab Clinical, Biomarker And Safety Data From Phase 2b Study Core And Open-Label Extension Across Five Years At Clinical Trials On Alzheimer's Disease (CTAD) Conference Biogen Announces Late Breakers and Additional New Data Presentations at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission Expected to Start in Early 2022 Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS Topline Results from Tofersen Phase 3 Study and its Open Label Extension in SOD1-ALS to be Presented at the American Neurological Association Annual Meeting New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis Sage Therapeutics and Biogen Announce Consistent Clinically Meaningful Data for Zuranolone Across the LANDSCAPE and NEST Clinical Development Programs Presented at the European College of Neuropsychopharmacology (ECNP) Congress Eisai Initiates Rolling Submission To The U.S. FDA For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer's Disease Under The Accelerated Approval Pathway Biogen R&D Day to Provide Overview of Diversified Pipeline and Capabilities with Potential for Multiple Novel Therapies in Neuroscience FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna) CHMP Recommends VUMERITY® (diroximel fumarate) for Approval in the European Union as a Treatment for Relapsing-Remitting Multiple Sclerosis Biogen Announces Positive Topline Results from Phase 2 CONVEY Study in Small Fiber Neuropathy Biogen Plans to Initiate Phase 3b Study Evaluating Potential Benefit of a Higher Dose of Nusinersen in Patients Previously Treated with Evrysdi® (risdiplam) Biogen Announces Results from Phase 3b NOVA Study Evaluating Every Six-Week Dosing with Natalizumab in Relapsing-Remitting Multiple Sclerosis Late-Breaking AAIC Presentation Explores Potential Clinical Effects Of Lecanemab (BAN2401) Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021 Biogen and Ionis report positive topline clinical data on investigational Alzheimer's disease treatment at AAIC Biogen and Eisai Announce ADUHELM™ (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021 Biogen to Present Data from ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference An open letter to the Alzheimer’s disease community from our Head of Research and Development, Alfred Sandrock, M.D., Ph.D. Mirimus, Inc. Forms Strategic Collaboration with Biogen to Develop RNAi-Based Therapeutics for Neurological Disease Indications Biogen and Innocare Announce License and Collaboration Agreement For Orelabrutinib, an Innovative CNS Penetrant BTK Inhibitor For the Potential Treatment of Multiple Sclerosis Collaboration Between AbbVie, Biogen and Pfizer Creates World’s Largest Browsable Resource Linking Rare Protein-Coding Genetic Variants to Human Health and Disease FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials Enel X Collaborates With Biogen To Electrify Take-home Vehicle Fleet In North America Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ™ Eisai And Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation For Lecanemab (BAN2401), An Anti-Amyloid Beta Protofibril Antibody For The Treatment Of Alzheimer's Disease Biogen Announces First Patient Dosed in Phase 3 Systemic Lupus Erythematosus Study Biogen Announces Topline Results From Phase 2 Study of Gosuranemab, an Anti-Tau Antibody, for Alzheimer’s Disease Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder Sage Therapeutics and Biogen Announce Positive Pivotal Phase 3 Results for Zuranolone, an Investigational Two-Week, Once-Daily Therapeutic Being Evaluated for Major Depressive Disorder Biogen Announces Topline Results from Phase 3 Gene Therapy Study in Choroideremia Biogen Announces Investor Day on September 21, 2021 New Data at Cure SMA 2021 Highlight the Long-Term Efficacy of SPINRAZA® (nusinersen) and Biogen’s Commitment to Innovation in SMA Therapy Biogen and Eisai launch multiple initiatives to help patients with Alzheimer’s disease access ADUHELM™ FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra® (Tocilizumab) Biogen and Ginkgo Bioworks Announce Collaboration and License Agreement to Develop Novel Gene Therapy Manufacturing Platform Swissmedic Grants Good Manufacturing Practice Multi-Product License to Biogen Biologics Facility in Solothurn, Switzerland Biogen Announces Topline Results From Phase 2/3 Gene Therapy Study for XLRP Biogen and Envisagenics Announce Collaboration to Advance RNA Splicing Research Biogen Announces Exercise of Option to Acquire the Investigational Drug TMS-007 for Acute Ischemic Stroke Based on Positive Phase 2a Data Biogen and Capsigen Announce Collaboration to Discover and Develop Novel AAV Capsids for Targeted CNS and Neuromuscular Disorders Biogen Provides Regulatory Update on the Supplemental Biologic License Application (sBLA) for Subcutaneous Administration of TYSABRI® (natalizumab) Biogen Releases 2020 Year in Review Demonstrating Its Commitment to Transparency and Progress across Environmental, Social and Governance Metrics 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer's Disease Published in Peer-Reviewed Journal, Alzheimer's Research and Therapy Biogen Advances Leading Research in Spinal Muscular Atrophy (SMA) with New Data at AAN 2021 Exploring Opportunities to Improve Outcomes for Patients New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis Biogen Grows Presence in China with the Approval of TECFIDERA® (dimethyl fumarate) for the Treatment of Relapsing Multiple Sclerosis Biogen to Present Trial Design of Aducanumab EMBARK Re-Dosing Study in Poster Session at 2021 Virtual AAN Annual Meeting on April 17-22, 2021 Sage Therapeutics and Biogen Announce SAGE-324 Phase 2 Placebo-Controlled KINETIC Study in Essential Tremor Met Primary Endpoint Biogen Announces Two New Nominees for Election to Board of Directors Biogen and Bio-Thera Solutions Announce Commercialization and License Agreement for Proposed Biosimilar Currently in Phase 3 With the Potential to Treat Moderate to Severe Rheumatoid Arthritis The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI® (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis Biogen Announces Plans to Build a New, State-of-the-Art Gene Therapy Manufacturing Facility in Research Triangle Park, North Carolina Life Science Cares and Biogen Foundation Help Launch Food For Free’s Just Eats Program Biogen Announces the Expiration Date Results of Its Cash Tender Offer Biogen Announces the Expiration Date Results of Its Private Exchange Offer Biogen and LabCentral Award Two Golden Tickets to Local and Innovative Science Startups Biogen Announces the Pricing Terms of its Cash Tender Offer Biogen Announces the Pricing Terms of Its Private Exchange Offer Biogen Announces Cash Tender Offer for 5.200% Senior Notes Due 2045 Open to Certain Holders Only Biogen Announces Private Exchange Offer for 5.200% Senior Notes Due 2045 Open to Certain Investors Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab Biogen to Launch Pioneering Study to Develop Digital Biomarkers of Cognitive Health Using Apple Watch and iPhone Biogen Announces First Patient Treated in RESPOND Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated With Zolgensma® (onasemnogene abeparvovec) The European Commission Grants Marketing Authorization for PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Relapsing-Remitting Multiple Sclerosis Biogen Files New Drug Application for Aducanumab in Japan Biogen and Sage Therapeutics Announce Global Collaboration to Develop and Commercialize Potential Breakthrough Therapies in Depression and Movement Disorders Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab) Biogen Ranked #1 Biotechnology Company by Dow Jones Sustainability World Index for an Industry Record 5th Time; Recognition Reflects Longstanding ESG Leadership ROSEN, A LEADING AND LONGSTANDING FIRM, Announces Investigation of Securities Claims Against Biogen Inc. - BIIB Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease Abarca Details First Value-Based Agreement For Medicaid Members Prescribed Biogen Products Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab) Biogen to Invest $250 Million in a 20-year Initiative to Eliminate its Use of Fossil Fuels and Improve Public Health New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio New Biogen Data Presented at ACTRIMS-ECTRIMS Advance Understanding of Clinical and Health Disparities in MS OneUnited Bank, Fintech Pioneer, Announces $10 Million Deposit By Biogen To Support #BankBlack Movement FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review Biogen and Denali to Collaborate on LRRK2 Program for Parkinson’s Disease and Certain TV Platform-Enabled Programs for Neurodegenerative Diseases Biogen Names Michael McDonnell as Executive Vice President and Chief Financial Officer Initiation Of New Phase III Clinical Study (AHEAD 3-45) Of BAN2401 Preclinical (Asymptomatic) Alzheimer's Disease Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020 Biogen Prices $3.0 Billion of Senior Unsecured Notes Biogen to Present Data at Virtual 2020 Alzheimer’s Association International Conference Highlighting Comprehensive Approach to Alzheimer’s Disease Biogen Plans to Initiate Phase 4 Study Evaluating Benefit of SPINRAZA® (nusinersen) in Patients Treated with Zolgensma® (onasemnogene abeparvovec) The New England Journal of Medicine Publishes Final Results from Phase 1/2 Study of Tofersen for a Genetic Form of ALS New Results From Landmark NURTURE Study Show That Pre-Symptomatic SMA Patients Treated With SPINRAZA® (nusinersen) Continue to Demonstrate Sustained Benefit From Treatment New SPINRAZA® (nusinersen) Data Reinforce Sustained Efficacy and Longer-Term Safety Across Broad Range of Spinal Muscular Atrophy (SMA) Patients