Biogen Inc.

BIIB

Held by 6 specialist biotech funds

High Convergence

6 funds opened new positions. Next phase2 readout (BG9924): May 2007. Short interest: 3.9% of float.

Drug Manufacturers - GeneralCEO: Christopher A. ViehbacherIPO: 1991Website ↗

Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases. The company offers TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for multiple sclerosis (MS); SPINRAZA for spinal muscular atrophy; and FUMADERM to treat plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; ADUHELM for the treatment of Alzheimer's disease; IMRALDI, an adalimumab biosimilar referencing HUMIRA; and FLIXABI, an infliximab biosimilar referencing REMICADE. In addition, the company offers RITUXAN for treating non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for treating relapsing MS and primary progressive MS; and other anti-CD20 therapies. Further, it develops BIIB135, BIIB061, BIIB091, and BIIB107 for MS and neuroimmunology; Aducanumab, Lecanemab, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB067, BIIB078, BIIB105, BIIB100, and BIIB110 to treat neuromuscular disorders; BIIB124, BIIB094, BIIB118, BIIB101, and BIIB122 for treating Parkinson's disease and movement disorders; BIIB125 and BIIB104 for treating neuropsychiatry; Dapirolizumab pegol and BIIB059 to treat immunology related diseases; BIIB093 and BIIB131 to treat acute neurology; BIIB074 for neuropathic pain; and BYOOVIZ, BIIB800, and SB15 biosimilars, which are under various stages of development. The company has collaboration and license agreements with Acorda Therapeutics, Inc.; Alkermes Pharma Ireland Limited; Denali Therapeutics Inc.; Eisai Co., Ltd.; Genentech, Inc.; Neurimmune SubOne AG; Ionis Pharmaceuticals, Inc.; Samsung Bioepis Co., Ltd.; Sangamo Therapeutics, Inc.; and Sage Therapeutics, Inc. Biogen Inc. was founded in 1978 and is headquartered in Cambridge, Massachusetts.

Catalysts

Phase 2Q1 2006Interferon Beta-1aChronic Inflammatory Demyelinating PolyradiculoneuropathyNCT00099489

Primary: The primary endpoint for the efficacy analyses is the total IVIg dose (g/Kg) administered after Visit 5 and through Visit 9 (Week 32, End of Study).Enrollment:Target 67Sites: 20RANDOMIZED, DOUBLE, TREATMENT

Phase 2PositiveQ1 2006BG00012Multiple SclerosisNCT00168701

Primary: The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24. (Weeks 12, 16, 20, and 24)Enrollment:260/260Sites: 42RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q2 2007BG9924Rheumatoid ArthritisNCT00292422

Primary: To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapyEnrollment:50/50Sites: 10RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2007BG00002-E (natalizumab high titer)Multiple SclerosisNCT00516893

Primary: Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status (Assessed every 12 weeks from Week 0 (Baseline) to Week 36)Enrollment:113/113Sites: 13NA

Phase 3PositiveQ4 2007BG00002 (natalizumab)Multiple Sclerosis, Relapsing-RemittingNCT00306592

Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs) (Baseline through Week 48)Enrollment:404/404Sites: 63NA, TREATMENT

Phase 2NegativeQ4 2008BG9924Rheumatoid ArthritisNCT00458861

Primary: Evaluate efficacy of BG9924 in combination with methotrexate in RA participants who have had an inadequate response to anti-TNF therapy (26 weeks)Enrollment:115/115Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ2 2012BG00002 (natalizumab)Relapsing Remitting Multiple SclerosisNCT01058005

Primary: Incidence of Treatment-emergent Serious Adverse Events (SAEs) (up to 108 Weeks)Enrollment:84/84Sites: 42RANDOMIZED

Phase 2NegativeQ1 2015natalizumabAcute Ischemic StrokeNCT01955707

Phase 3PositiveQ4 2015peginterferon beta-1aRelapsing Multiple SclerosisNCT01332019

Primary: Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs (up to 4 years)Enrollment:1,077/1,077Sites: 151NON_RANDOMIZED, TREATMENT

Phase 3Q1 2016fampridineMultiple SclerosisNCT02219932

Primary: Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks (Baseline to 24 weeks)Enrollment:646/646Sites: 87RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2016BIIB019 (Daclizumab)Relapsing-Remitting Multiple SclerosisNCT01051349

Phase 2PositiveQ4 2016BIIB074Primary Inherited ErythromelalgiaNCT02917187

Primary: Weekly average severity of paroxysms (Day 1 to Week 12)Enrollment:8/8Sites: 5RANDOMIZED, TRIPLE, TREATMENT

Phase 2PositiveQ3 2017nusinersenSpinal Muscular AtrophyNCT01839656

Phase 2ApprovedQ3 2018NusinersenSpinal Muscular AtrophyNCT02462759

Phase 3NegativeQ3 2019Aducanumab (BIIB037)Alzheimer's DiseaseNCT02484547

Primary: Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78 (Baseline, Week 78)Enrollment:1,643/1,643Sites: 180RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2020Placebo Oral CapsuleAlport SyndromeNCT03019185

Primary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks of Treatment (Phase 2) (Baseline through 12 weeks after participant receives the first dose in the Phase 2 study)Enrollment:187/187Sites: 63RANDOMIZED, TRIPLE, TREATMENT

Phase 2NegativeQ4 2020PlaceboParkinson's DiseaseNCT03318523

Phase 3Q2 2021ALKS 8700Multiple SclerosisNCT02634307

Phase 2Q4 2021Bardoxolone methyl oral capsuleChronic Kidney DiseasesNCT04702997

Primary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 (Baseline through 12 weeks after participant receives the first dose)Enrollment:81/81Sites: 12RANDOMIZED, TRIPLE, TREATMENT

Phase 3PositiveQ4 2021SAGE-217Depressive Disorder, MajorNCT04476030

Phase 3PositiveQ1 2022SAGE-217Depression, PostpartumNCT04442503

Phase 2Q1 2022BIIB104Cognitive Impairment Associated With SchizophreniaNCT03745820

Phase 3PositiveQ2 2023SAGE-217Major Depressive DisorderNCT03864614

Phase 3NegativeQ3 2023Bardoxolone methylChronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic KidneyNCT03749447

Phase 2Q4 2023MOR202Glomerulonephritis, Membranous Nephropathy, anti PLA2R PositiveNCT04733040

Phase 3Q3 2024TofersenALS Caused by Superoxide Dismutase 1 (SOD1) MutationNCT03070119

Phase 2Q1 2026BIIB091Relapsing Forms of Multiple SclerosisNCT05798520

Phase 2Q1 2026BIIB122Parkinson DiseaseNCT05348785

Primary: Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score Over the Treatment Period (Up to Week 144)Enrollment:650/650Sites: 113RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Apr 30, 2026BIIB122 225 mgParkinson DiseaseNCT06602193

Phase 2Q2 2026BIIB080Mild Cognitive Impairment Due to Alzheimer's Disease, Alzheimer's Disease DementiaNCT05399888

Phase 3Q2 2026Choroideremia, X-Linked Retinitis PigmentosaNCT03584165

Phase 3Q3 2026NusinersenMuscular Atrophy, SpinalNCT04729907

Phase 3Q3 2026LitifilimabLupus Erythematosus, SystemicNCT04961567

Phase 3Q3 2026LitifilimabLupus Erythematosus, SystemicNCT04895241

Phase 3Q4 2026LitifilimabSubacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus ErythematosusNCT05531565

Phase 3Q4 2026FelzartamabAntibody-mediated RejectionNCT06685757

Phase 2Q1 2027TofersenALS (Amyotrophic Lateral Sclerosis)NCT07294144

Phase 3Q1 2027baricitinib treatmentRheumatoid ArthritisNCT04870203

Phase 3Q2 2027BIIB017 (peginterferon beta-1a)Multiple Sclerosis, Relapsing-RemittingNCT03958877

Primary: Part 1: Annualized Relapse Rate (ARR) at Week 48 (Week 48)Enrollment:152/152Sites: 65RANDOMIZED, TREATMENT

Phase 3Q2 2027FelzartamabImmunoglobulin A Nephropathy (Ig AN)NCT06935357

Phase 3Q3 2027TofersenAmyotrophic Lateral Sclerosis Associated With a SOD1 Gene MutationNCT04856982

Phase 3Q3 2027NusinersenSpinal Muscular AtrophyNCT05067790

Phase 2Oct 31, 2027Tyruko Injectable ProductMultiple Sclerosis, Clinically Isolated Syndrome of DemyelinationNCT05418010

Phase 3Q4 2027OmaveloxoloneFriedreich AtaxiaNCT06953583

Phase 2Q1 2028FelzartamabGraves' DiseaseNCT07722546

Phase 2Q1 2028FelzartamabMicrovascular InflammationNCT07219043

Phase 3Q2 2028SalanersenSpinal Muscular AtrophyNCT07444476

Phase 3Q4 2028SalanersenMuscular Atrophy, SpinalNCT07221669

Phase 3Dec 21, 2028LecanemabPreclinical Alzheimer's Disease, Early Preclinical Alzheimer's DiseaseNCT04468659

Phase 3Q4 2028FelzartamabPrimary Membranous NephropathyNCT06962800

Primary: Percentage of Participants who Achieve Complete Remission (CR) at Week 104 (Week 104)Enrollment:Target 180Sites: 91RANDOMIZED, TREATMENT

Phase 3Q2 2029BIIB059 (litifilimab)Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus ErythematosusNCT06044337

Phase 3Jun 30, 2029Lecanemab IVEarly Alzheimer's DiseaseNCT03887455

Phase 3Q3 2029SalanersenMuscular Atrophy, SpinalNCT07444450

Phase 3Q1 2030LitifilimabSystemic Lupus Erythematosus (SLE)NCT05352919

Primary: Number of Participants with Treatment Emergent Adverse Events (TEAEs) (Up to Week 180)Enrollment:Target 864Sites: 183RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2031FelzartamabAntibody-mediated Rejection, Microvascular InflammationNCT07444489

Phase 3Q3 2034Diroximel FumarateRelapsing Forms of Multiple SclerosisNCT07483632

Primary: TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation (Cohort A: From first dose of study drug up to end of follow-up (up to Week 104), OLE: Baseline (Week 96) up to the end of OLE period (up to Week 196))Enrollment:Target 185RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2TBDRTA 402 Dose1Malignant MelanomaNCT00535314

Primary: To determine the proportion of patients without progression at 6 months in patients with unresectable Stage III or Stage IV melanoma treated with RTA 402.0RANDOMIZED, TREATMENT

Phase 2TBDPlaceboSecondary Progressive Multiple SclerosisNCT01181089

Primary: Measure: Change in cerebrospinal fluid levels of secondary lymphoid organs chemokines from baseline with baminercept relative to placebo (after 4 months of treatment)0RANDOMIZED, TRIPLE, TREATMENT

Phase 3TBDrituximabLow-Grade or Follicular B-Cell Non-Hodgkin's LymphomaNCT00168740

Primary: overall response rateEnrollment:Target 150Sites: 31NON_RANDOMIZED, TREATMENT

Phase 3NegativeTBDZevalin (ibritumomab tiuxetan)Non-Hodgkin's LymphomaNCT00057343

Primary: Event-free survivalEnrollment:Target 400Sites: 67RANDOMIZED, TREATMENT

Recent News & Research

PubMed

β-Cell Function and Diabetes Outcomes 1 Year After Stopping Oral Baricitinib Immunotherapy for Type 1 Diabetes.

# Investment Summary: Biogen Baricitinib Type 1 Diabetes Study **Clinical Finding:** This study evaluates durability of β-cell function one year after discontinuing baricitinib (an oral JAK inhibitor) in type 1 diabetes patients, assessing whether disease-modifying benefits persist post-treatment. **Investment Implication:** The data directly impact baricitinib's commercial viability in type 1 diabetes as a potential disease-modifying therapy. Key outcomes—whether β-cell preservation sustains off-drug and how quickly function declines—will determine dosing strategies (continuous vs. intermittent), treatment duration expectations, and competitive positioning against other immunotherapies; positive durability could support premium pricing and label expansion, while rapid function loss post-discontinuation would limit addressable market and differentiation. **Bottom Line:** Results will clarify whether baricitinib offers disease modification or temporary

Aug 21, 2026

PubMed

Nusinersen effectiveness and safety in children with type II/III 5q-spinal muscular atrophy: Second interim analysis from a Chinese disease registry.

# Investment Summary: Nusinersen in Chinese SMA Population **Clinical Finding:** This second interim analysis from a Chinese disease registry demonstrates nusinersen's continued effectiveness and safety profile in pediatric Type II/III SMA patients, providing real-world evidence in an underserved population outside Western clinical trial cohorts. **Commercial Implication:** The data supports nusinersen's market penetration in China—a key growth opportunity for Biogen—by validating clinical benefits in the target pediatric population and potentially facilitating reimbursement discussions with Chinese health authorities. However, investors should note this occurs in a competitive landscape with newer SMA therapies (including gene therapies and oral SMN2 splicing modulators) that may offer dosing/access advantages in emerging markets.

Aug 20, 2026

PubMed

Longitudinal Dosing Patterns and Treatment Costs Among Patients with Spinal Muscular Atrophy Initiating Nusinersen and Risdiplam.

# Investment Summary: Biogen SMA Treatment Economics **Clinical/Commercial Findings:** This study examines real-world dosing patterns and cost trajectories for Biogen's nusinersen (Spinraza) and risdiplam (Evrysdi) in SMA patients, likely revealing actual treatment utilization versus label recommendations and associated healthcare expenditures. Understanding longitudinal dosing adherence and cost structures is critical for modeling revenue sustainability and payer reimbursement pressures in Biogen's largest revenue contributor. **Why It Matters:** The data could indicate whether patients maintain on-label dosing schedules (affecting peak sales potential) and quantify total cost-of-care, which directly influences payer willingness to cover these therapies at current prices—a key variable for BIIB's SMA franchise revenue forecasts and market access risk in competitive geographies.

Aug 6, 2026

PubMed

Lecanemab use in Chinese patients with Alzheimer's disease: a 12-month multicenter real-world study.

# Investment Summary: Lecanemab in Chinese AD Patients This real-world study demonstrates lecanemab's safety and efficacy in Chinese Alzheimer's disease patients over 12 months, establishing clinical validation in a population representing ~20% of the global AD market that was underrepresented in pivotal trials. The data supports Biogen's geographic expansion strategy and potential for market penetration in China, where regulatory pathways for amyloid-targeting therapies are opening following NMPA approvals of similar agents. Positive real-world outcomes strengthen the commercial case for lecanemab adoption in Asia-Pacific markets and could justify higher pricing/reimbursement discussions in this high-prevalence region, though adoption barriers (cost, infusion infrastructure, amyloid screening capacity) remain material execution risks.

Aug 1, 2026

PubMed

Reply: Statistical power, amyloid-related imaging abnormality ascertainment and inclusion criteria in lecanemab cohorts.

# Investment Summary: Lecanemab Statistical/Safety Debate This reply addresses methodological criticisms regarding lecanemab's clinical trial design, specifically concerning statistical power, ARIA (amyloid-related imaging abnormality) detection protocols, and patient selection criteria. The response is material because unresolved questions about trial rigor or ARIA ascertainment could impact regulatory confidence, payer coverage decisions, or future label restrictions for this key Alzheimer's asset. For BIIB investors, this signals ongoing scientific scrutiny of lecanemab's evidence base that may influence commercial uptake or long-term liability exposure. **Bottom line:** Methodological debates don't change approved status but can affect reimbursement rates and market penetration if they amplify safety concerns or reduce physician/patient adoption confidence.

Aug 1, 2026

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