Welcome to our dedicated page for Biogen news (Ticker: BIIB), a resource for investors and traders seeking the latest updates and insights on Biogen stock.
Biogen Inc. (NASDAQ: BIIB) generates frequent news across neurology, rare diseases and immunology, reflecting its role as a biotechnology company focused on serious neurological and genetic conditions. News coverage for BIIB often centers on clinical trial results, regulatory milestones, scientific publications and strategic collaborations that shape the company’s therapeutic portfolio.
Investors and healthcare observers following Biogen news can expect updates on marketed therapies such as SPINRAZA (nusinersen) for 5q spinal muscular atrophy, QALSODY (tofersen) for SOD1-ALS, and LEQEMBI (lecanemab-irmb) for early Alzheimer’s disease, co-developed with Eisai. Recent announcements have included European Commission approval of a high-dose SPINRAZA regimen, long-term QALSODY data published in JAMA Neurology, and multiple LEQEMBI data presentations at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference, including subcutaneous administration and long-term treatment analyses.
Biogen news also highlights its collaborations and pipeline. Examples include joint updates with Stoke Therapeutics on zorevunersen, an investigational antisense oligonucleotide for Dravet syndrome, and a research collaboration with Dayra Therapeutics to discover oral macrocyclic peptides for immunological conditions. In addition, the company regularly issues press releases on scientific conference presentations, regulatory submissions, and its broader ALS and Alzheimer’s research programs.
This BIIB news page aggregates such developments in one place, helping readers track Biogen’s clinical progress, regulatory interactions and research directions over time. For investors, clinicians and researchers, it offers a focused view of how Biogen’s scientific and business activities evolve across its key therapeutic areas.
Biogen announces a multi-year virtual research study in collaboration with Apple to explore digital biomarkers for monitoring cognitive performance and detecting mild cognitive impairment (MCI). Set to launch in 2021, the study will enroll diverse participants to enhance understanding of cognitive health through Apple technology. MCI affects approximately 15-20% of adults over 65, but diagnosis often faces delays. The initiative aims to empower patients and healthcare providers by accelerating diagnoses and improving health outcomes while ensuring participant data privacy and security.
Biogen (Nasdaq: BIIB) has launched the Phase 4 RESPOND study to assess the efficacy and safety of SPINRAZA in children with spinal muscular atrophy (SMA) who have had suboptimal responses to Zolgensma. The study will include around 60 patients across 20 sites globally. It aims to explore if SPINRAZA can provide additional benefits by increasing survival motor neuron (SMN) protein production in previously treated patients. The two-year study will focus on various clinical endpoints, including motor function and safety.
Biogen has received European Commission approval for PLEGRIDY® (peginterferon beta-1a) for intramuscular (IM) injection, increasing treatment options for patients with relapsing multiple sclerosis (MS). This new route offers a reliable treatment option with a well-characterized safety profile and fewer injection site reactions compared to subcutaneous (SC) administration (14.4% vs. 32.1%). PLEGRIDY is already available in over 60 countries, and Biogen is pursuing similar regulatory approval in the U.S. This enhances Biogen's comprehensive MS portfolio aimed at meeting diverse patient needs.
Biogen has submitted a New Drug Application (J-NDA) for aducanumab to Japan's Ministry of Health, Labor and Welfare. If approved, aducanumab would be the first treatment to significantly alter the course of Alzheimer’s disease. The drug targets amyloid beta and has shown promise in clinical trials for slowing clinical decline in patients with Mild Cognitive Impairment and mild Alzheimer's disease dementia. Aducanumab is also undergoing regulatory reviews in the U.S. and Europe, with the FDA expected to make a decision by March 7, 2021.
Biogen and Sage Therapeutics have entered a global collaboration to jointly develop and commercialize zuranolone and SAGE-324 for various mental health disorders and essential tremor in the U.S. Biogen will also have an exclusive license for zuranolone outside the U.S., excluding certain Asian markets. Sage will receive $1.525 billion in cash, including an $875 million upfront payment and a $650 million equity investment. The collaboration aims to address the unmet medical needs in depression, with potential milestone payments of up to $1.6 billion.
On November 18, 2020, Samsung Bioepis and Biogen announced that the FDA accepted the Biologics License Application for SB11, a biosimilar to Lucentis® (ranibizumab), aimed at treating retinal vascular disorders, a leading cause of blindness in the U.S.
This milestone could significantly improve access to affordable therapies, with projected savings exceeding $100 billion over five years from biosimilars in the U.S. If approved, SB11 is expected to help millions of patients.
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The FDA Advisory Committee evaluated aducanumab for Alzheimer's treatment, resulting in a 1 yes, 8 no vote on its effectiveness based on Study 302. Study 103 received 0 yes votes supporting its efficacy. The committee expressed skepticism about aducanumab's primary evidence as effectiveness. Biogen CEO Michel Vounatsos acknowledged the unmet need for Alzheimer's treatment and emphasized ongoing FDA collaboration. The FDA aims to make a decision by March 7, 2021. Aducanumab, if approved, could be the first meaningful treatment altering Alzheimer's progression.
Biogen announced positive results from the Phase 2 LILAC study of BIIB059, a monoclonal antibody targeting BDCA2, for systemic lupus erythematosus (SLE). The study demonstrated a statistically significant reduction in total active joint count by 3.4 at 24 weeks (p=0.037) compared to placebo. The SLE Responder Index-4 (SRI-4) showed a higher response rate of 56.77% for BIIB059 versus 30.42% for placebo (p=0.003). Mild to moderate adverse events occurred in the majority, with serious events at 5.3% for BIIB059. Biogen aims to advance BIIB059 into Phase 3 trials, reinforcing its commitment to lupus treatment.
Biogen (Nasdaq: BIIB) and Eisai announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for aducanumab, an experimental Alzheimer’s disease treatment. If approved, aducanumab would be the first therapy to significantly alter the course of Alzheimer’s. Clinical trials demonstrated its ability to remove amyloid beta and improve clinical outcomes, indicating potential in slowing cognitive decline. Aducanumab is also under U.S. FDA review with a decision expected by March 7, 2021.