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) is a pioneering biotechnology company founded in 1978, dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological and neurodegenerative diseases. With a robust portfolio of medicines, Biogen is a global leader in the treatment of multiple sclerosis (MS) and has introduced the first and only approved treatment for spinal muscular atrophy (SMA). The company is also at the forefront of research for Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS).
Headquartered in Cambridge, Massachusetts, Biogen operates worldwide with research facilities in Zug, Switzerland, and state-of-the-art manufacturing plants in North Carolina and Denmark. The company employs approximately 7,000 people globally, emphasizing a collaborative and inclusive work environment.
Biogen's significant achievements include the development of revolutionary MS treatments such as Avonex, Plegridy, Tysabri, Tecfidera, and Vumerity. The company also markets Spinraza for SMA and Leqembi for Alzheimer’s disease, in collaboration with partners like Ionis and Eisai respectively. Biogen continues to expand its pipeline with promising candidates currently in various stages of clinical trials.
Recent developments have seen Biogen and Eisai submit a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for monthly maintenance dosing of Leqembi, aimed at treating Alzheimer's disease in its early stages. Furthermore, Biogen published its 2023 Corporate Responsibility Report, highlighting its commitment to sustainable practices and social responsibility across four key pillars.
In addition to its core operations, Biogen collaborates with companies like Delta Flight Products to improve travel experiences for passengers with reduced mobility. This initiative reflects Biogen’s broader mission to enhance the quality of life for individuals facing debilitating conditions.
Biogen's financial health is robust, with strategic mergers and acquisitions like the recent purchase of Human Immunology Biosciences for $1.15 billion, aiming to bolster its immunology pipeline. The company’s comprehensive approach to business involves balancing bold scientific endeavors with prudent financial management to ensure long-term growth and shareholder value.
For more information about Biogen's latest news and updates, visit www.biogen.com.
On July 8, 2021, Biogen, in collaboration with AbbVie and Pfizer, launched a new browser that links rare protein-coding genetic variants to human health. This resource is based on whole exome sequencing data from 300,000 UK Biobank participants, allowing global scientists to explore genetic associations with diseases. Managed by the Broad Institute, the platform aims to advance our understanding of genetic diseases and potentially guide therapeutic strategies. The UK Biobank project supports collaborative research in identifying links between genetics and health.
Biogen has received FDA approval for an updated label for ADUHELM (aducanumab-avwa), indicating that treatment should begin in patients with mild cognitive impairment or mild Alzheimer’s dementia. This clarification highlights the population studied in clinical trials and reinforces that there are no data supporting treatment initiation at different disease stages. The indication was granted under accelerated approval, contingent on future confirmatory trials. Alfred Sandrock emphasized the company’s commitment to aligning treatment practices with community needs.
Enel X is partnering with Biogen (Nasdaq: BIIB) to electrify its global fleet of over 1,000 vehicles by 2025. This initiative supports Biogen's commitment to a fossil fuel-free future by 2040 and aims to reduce emissions by at least 7,000 pounds of CO2 per electric vehicle annually. Enel X will provide JuiceBox charging stations and IoT software to optimize fleet management and reduce operating costs. The collaboration enhances Biogen's Healthy Climate, Healthy Lives initiative, contributing to climate change and public health goals.
Samsung Bioepis and Biogen (Nasdaq: BIIB) announced that the European Medicines Agency’s CHMP has issued a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®. BYOOVIZ is recommended for treating serious retinal disorders, including wet age-related macular degeneration and diabetic retinopathy. This opinion will be forwarded to the European Commission for final marketing authorization. If approved, BYOOVIZ will expand Biogen's biosimilars portfolio, enhancing patient access to vital treatments for retinal vascular diseases.
Eisai and Biogen announced that the FDA has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational antibody aimed at treating Alzheimer's disease. This designation facilitates faster drug development for serious conditions. The decision is based on positive Phase 2b trial outcomes involving 856 patients, demonstrating a reduction in clinical decline associated with Alzheimer's. The companies are also conducting additional studies, including the Clarity AD and AHEAD 3-45 trials. The prospects depend on ongoing clinical successes and regulatory reviews.
Biogen has initiated the global Phase 3 TOPAZ-1 study to assess the efficacy and safety of BIIB059, a monoclonal antibody targeting blood dendritic cell antigen 2, in patients with active systemic lupus erythematosus (SLE). Following positive results from the Phase 2 LILAC study, which demonstrated significant disease activity reduction, the TOPAZ-1 trial will enroll 540 adults at around 135 locations worldwide. This study aims to provide a new therapeutic option for SLE, especially affecting diverse populations.
Biogen (Nasdaq: BIIB) announced that its Phase 2 TANGO study of gosuranemab, an investigational anti-tau antibody aimed at treating Alzheimer’s disease, did not achieve its primary efficacy endpoint. The study, involving 654 participants over 78 weeks, showed no significant treatment benefit compared to placebo on key cognitive scales. Although gosuranemab was well-tolerated, the study has been terminated, and clinical development of the drug will discontinue. Biogen will continue to analyze data and will present results at a medical congress.
The WATERFALL Study conducted by Sage Therapeutics and Biogen reported positive results for zuranolone (50 mg) in treating major depressive disorder (MDD). At Day 15, patients showed a significant reduction in depressive symptoms (HAMD-17 score, p=0.0141) compared to placebo. The drug demonstrated a rapid onset of effect and a high completion rate of 90.3%. Zuranolone was generally well-tolerated, with treatment emergent adverse events (TEAEs) at 60.1%. The study highlights zuranolone's potential as a new class of rapid-acting antidepressant, promising a breakthrough in MDD treatment.
Sage Therapeutics and Biogen announced that the Phase 3 WATERFALL Study for zuranolone (SAGE-217/BIIB125) in Major Depressive Disorder (MDD) met its primary endpoint. Zuranolone 50 mg showed a significant improvement in depressive symptoms compared to placebo, with a mean change from baseline in HAMD-17 total score at Day 15 of -14.1 versus -12.3 for placebo (p=0.0141). Zuranolone demonstrated a favorable safety profile, with common adverse events being mild to moderate. The U.S. FDA has granted Breakthrough Therapy Designation for zuranolone, indicating its potential as a new treatment option.
Biogen announced the Phase 3 STAR study results for timrepigene emparvovec (BIIB111/AAV2-REP1), aimed at treating choroideremia, a rare retinal disease. Unfortunately, the study did not achieve its primary endpoint of a ≥15 letter improvement in best corrected visual acuity at Month 12 compared to a control group. Additionally, key secondary endpoints were also unmet. Despite the disappointing results, Biogen emphasized the importance of the insights gained for future therapeutic innovations. The company will analyze the full data set to determine the next steps for the clinical development program.
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