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.
Biogen has announced that its new manufacturing facility in Solothurn, Switzerland, has received GMP multi-product licensure from SWISSMEDIC. This facility utilizes advanced cell culture technology for large-scale biopharmaceutical production. With over 500 employees, it is equipped to manufacture products like aducanumab and lecanemab. Additionally, the site aims for significant sustainability improvements, including an 83% reduction in carbon emissions and a goal to be fossil fuel-free by 2040, enhancing Biogen's ability to deliver high-quality therapies to patients.
Biogen announced topline results from the Phase 2/3 XIRIUS study for cotoretigene toliparvovec (BIIB112), a gene therapy for X-linked retinitis pigmentosa (XLRP). While the study did not meet its primary endpoint, positive trends were observed in secondary endpoints, particularly in visual acuity measures. The company plans to analyze complete data before determining next steps. Currently, there are no approved treatments for XLRP, a rare inherited retinal condition leading to vision loss and blindness.
Biogen has formed a collaboration with Envisagenics to utilize their AI-driven RNA splicing platform, SpliceCore®, to enhance research on Central Nervous System (CNS) diseases. This partnership aims to analyze RNA isoforms and their regulation, potentially leading to the identification of new drug targets. Envisagenics' platform offers access to a database of 7 million RNA splicing errors, significantly improving the efficiency of splicing error detection compared to traditional methods. This collaboration aligns with Biogen's goals in CNS drug discovery.
Biogen has exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, following promising results from a Phase 2a study. The study reported no incidences of symptomatic intracranial hemorrhage (sICH) and significant improvements in blood vessel reopening and patient recovery. Biogen will pay $18 million upfront, with potential additional payments of up to $335 million based on milestones. This acquisition aims to extend the treatment window for thrombolytic therapy beyond the current limitations, addressing a vital unmet medical need in stroke care.
Biogen (Nasdaq: BIIB) and Capsigen have launched a strategic research collaboration to develop novel adeno-associated virus (AAV) capsids aimed at advancing gene therapies for CNS and neuromuscular disorders. Utilizing Capsigen's TRADE™ platform, the partnership focuses on creating customized capsids for targeted disease profiles. Capsigen will receive a $15 million upfront payment, with potential milestones totaling up to $1.25 billion. This collaboration aims to enhance Biogen's gene therapy pipeline and accelerate the delivery of innovative treatments to patients.
Biogen has received a Complete Response Letter (CRL) from the FDA for its supplemental Biologic License Application for a subcutaneous delivery method of TYSABRI (natalizumab) to treat multiple sclerosis. The FDA's response indicates the filing cannot be approved as it stands. Biogen is reviewing the CRL and will decide on further actions. However, the intravenous administration of TYSABRI remains unaffected and continues to be a viable treatment for relapsing MS. The subcutaneous delivery was approved in March 2021 by the European Commission, and Biogen intends to pursue regulatory filings in other countries.
Biogen (Nasdaq: BIIB) released its 2020 Year in Review, highlighting its commitment to climate, health, and equity. The report reveals 11% reduction in absolute emissions and 10% in water withdrawal compared to 2019. Noteworthy goals include PVC-free packaging by 2025 and enhancing diversity in clinical trials. Additionally, the company has tied part of its employees' compensation to ESG metrics and disclosed pay equity analysis results indicating 99.7% alignment with equal pay principles. Biogen also invested over $90 million to support communities during the COVID-19 pandemic.
Eisai Co., Ltd. and Biogen Inc. announced the publication of a Phase 2b clinical trial for lecanemab (BAN2401), an investigational antibody for Alzheimer's disease, in the journal Alzheimer's Research and Therapy. The study reported a consistent reduction in clinical decline across multiple endpoints, supporting its potential for treating early Alzheimer's. The ongoing Phase 3 Clarity AD trial, which includes 1,795 symptomatic patients, aims to confirm these findings. The trials focus on reducing amyloid beta aggregates, which are believed to contribute to the disease's progression.
Biogen (Nasdaq: BIIB) announced significant data from the SPINRAZA clinical development program at the American Academy of Neurology 2021 Virtual Annual Meeting. The DEVOTE study indicates no new safety concerns when using a higher dose of SPINRAZA (nusinersen). With the ongoing development aimed at optimizing outcomes for spinal muscular atrophy (SMA) patients, the study explores a higher dose regimen, which includes two loading doses of 50 mg followed by maintenance doses. Additionally, research on biomarkers and digital tools aims to enhance treatment strategies for SMA.
Biogen announced new findings regarding its multiple sclerosis (MS) therapies, particularly TYSABRI and VUMERITY, at the AAN 2021 Virtual Meeting. TYSABRI showed significant improvements in quality of life metrics compared to Ocrevus, with greater enhancements in areas like social roles and emotional management. Additionally, VUMERITY's gastrointestinal tolerability was validated in real-world settings, with a low discontinuation rate due to side effects. These findings reinforce Biogen's dedication to advancing MS treatment through innovative research and real-world evidence.
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