Biogen Inc.

BIIB

Held by 6 specialist biotech funds

High Convergence

6 funds opened new positions. Next phase3 readout (peginterferon beta-1a): Oct 2015. 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 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 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 2PositiveQ4 2016BIIB074Primary Inherited ErythromelalgiaNCT02917187

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

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 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 3PositiveQ2 2023SAGE-217Major Depressive DisorderNCT03864614

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

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 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 RejectionNCT07444489

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

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

Recent News & Research

PubMed

The prevalence of spinal muscular atrophy in Kazakhstan and the experience with the national nusinersen treatment program.

# Investment Summary This study documents Kazakhstan's national implementation of nusinersen (Spinraza, Biogen's SMA treatment) and establishes local SMA prevalence data, providing evidence of the drug's real-world utilization in an emerging market with previously unquantified patient populations. The data supports market expansion potential in Central Asian regions and demonstrates feasibility of administering Biogen's therapy in healthcare systems outside traditional developed markets. This geographic diversification and evidence of adoption in underserved populations could modestly strengthen Biogen's long-term revenue sustainability for Spinraza, though the market size impact is likely limited relative to core markets.

Jul 2, 2026

PubMed

Number needed to treat and harm for lecanemab and donanemab in early Alzheimer disease.

# Investment Summary: Lecanemab and Donanemab NNT/NNH Analysis **Clinical Finding:** This comparative analysis of number-needed-to-treat (NNT) and number-needed-to-harm (NNH) metrics for Biogen's lecanemab and competitor donanemab in early Alzheimer's disease quantifies the clinical benefit-risk tradeoff for both monoclonal antibodies targeting amyloid-beta pathology. **Investment Relevance:** The NNT/NNH comparison directly impacts market positioning and reimbursement negotiations—payers increasingly require favorable benefit-harm ratios to justify premium pricing and broad adoption. If lecanemab shows less favorable metrics than donanemab (higher NNT or lower NNH), it could constrain peak sales forecasts and erode competitive advantage in the ~$10B early AD market, particularly

Jul 1, 2026

PubMed

Quantifying Short-Term Functional Changes After Lecanemab Treatment in Early Alzheimer's Disease: An Exploratory 3-Month Follow-Up Case Report Using Eye Movement and Gait Analysis.

# Investment Summary: Lecanemab Short-Term Functional Outcomes This case report demonstrates measurable functional improvements in eye movement and gait metrics within 3 months of lecanemab treatment in early Alzheimer's disease, suggesting the drug may produce detectable cognitive-motor benefits earlier than traditional endpoints. While limited to a single case, these biomarkers could strengthen future trial designs and support label expansions or real-world efficacy claims. For Biogen, early functional improvements may support premium pricing positioning and differentiation versus competitors, though regulatory acceptance of novel gait/eye-tracking endpoints remains uncertain. **Investment relevance:** Validates potential for short-term clinical readouts that could accelerate market adoption narratives, but significance contingent on larger dataset confirmation and payer acceptance of non-standard efficacy measures.

Jun 29, 2026

PubMed

Lecanemab in practice: AI-derived MRI predictors of benefit and Amyloid Related Imaging Abnormalities (ARIA).

# Lecanemab Clinical Utility Summary **Study Finding:** Researchers identified AI-derived MRI biomarkers that predict which Alzheimer's patients will benefit from lecanemab treatment and those at risk for amyloid-related imaging abnormalities (ARIA), the drug's primary safety concern. **Investment Relevance:** This has meaningful commercial implications for Biogen's lecanemab franchise—predictive biomarkers could expand the treatable patient population by enabling better patient selection, potentially reducing trial failures in future indications and strengthening real-world adoption by de-risking ARIA complications. However, the value depends on whether these MRI-derived predictors achieve clinical adoption and whether they expand or simply optimize the existing market within currently approved indications.

Jun 29, 2026

PubMed

Lung Function and Respiratory Muscle Strength in Symptomatic Children and Adults With Spinal Muscular Atrophy Treated With Nusinersen.

# Investment Summary: Nusinersen Respiratory Data in SMA This study demonstrates that nusinersen treatment produces measurable improvements in lung function and respiratory muscle strength across pediatric and adult SMA patients, expanding the clinical evidence base beyond motor function endpoints. The respiratory findings are commercially relevant because they support broader therapeutic claims, strengthen competitive positioning against newer competitors (like risdiplam and gene therapy), and may justify premium pricing or expanded insurance coverage by demonstrating clinically meaningful benefits in a complication that significantly impacts SMA morbidity and mortality. The data could also support label expansion or real-world effectiveness arguments, though the investment impact depends on whether these respiratory improvements translate to reduced hospitalizations/interventions that payers recognize as cost-offsets—a determination requiring economic analysis not evident in the abstract.

Jun 9, 2026

Biogen Inc.

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