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November 22, 2021

Statement on JAMA Neurology Publication about Amyloid-Related Imaging Abnormalities in Two Phase 3 Studies Evaluating Aducanumab in Early Alzheimer’s Disease

Today, Biogen and Eisai announced that the Journal of the American Medical Association (JAMA) Neurology published a peer-reviewed paper about findings around amyloid-related imaging abnormalities (ARIA) in the Phase 3 trials of ADUHELM (aducanumab-avwa).

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October 19, 2021

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

Following the pre-NDA meeting, the companies confirmed t he current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD The planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter

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October 17, 2021

Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS

In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple secondary and exploratory endpoints were observed The

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October 14, 2021

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

CAMBRIDGE, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense oligonucleotide (ASO) drug being evaluated for people with superoxide dismutase 1 ( SOD1 )

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October 13, 2021

New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience

Full analysis of Phase 3b NOVA study provides insights on efficacy of every six-week dosing with natalizumab as compared to the approved every four-week dosing Real-world analysis shows significantly lower risk of relapse for patients treated with TYSABRI ® compared to Ocrevus ® (ocrelizumab) New

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October 13, 2021

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

MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination Data from this analysis also suggest that approximately 40 percent of people with MS treated with anti-CD20 and S1P

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October 6, 2021

Biogen to Report Third Quarter 2021 Financial Results October 20, 2021

Cambridge, Mass.— Biogen Inc. (Nasdaq:BIIB) today announced it will report third quarter 2021 financial results Wednesday, October 20, 2021, before the financial markets open.  Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET.

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October 4, 2021

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

Improvement achieved in measurements of overall quality of life, functioning and general well-being achieved at Day 15 and sustained at Day 42 Consistent and differentiated safety and tolerability profile seen across clinical program Sage to host conference call on October 4, 2021 at 8:00am ET

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September 27, 2021

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

LECANEMAB IS AN ANTI-AMYLOID BETA (Aβ) PROTOFIBRIL ANTIBODY  TOKYO and CAMBRIDGE, Mass, Sep. 28, 2021  - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced

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September 21, 2021

Biogen R&D Day to Provide Overview of Diversified Pipeline and Capabilities with Potential for Multiple Novel Therapies in Neuroscience

33 early and late-stage clinical programs across modalities and innovative discovery platforms Uniquely positioned to lead in Alzheimer’s disease with ADUHELM ® (aducanumab-avwa) and industry-leading pipeline including Phase 3 lecanemab Potential to transform standard of care in several areas of

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September 20, 2021

FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna)

BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in the United States INCHEON, Korea and CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S.