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.
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.
Biogen has received approval from China's National Medical Products Administration (NMPA) for TECFIDERA (dimethyl fumarate) to treat relapsing multiple sclerosis (MS). This well-established treatment has been administered to over 500,000 patients worldwide since its 2013 introduction. The approval, which followed a priority review, allows Biogen to expand its presence in China, where only about 10% of those diagnosed with MS receive disease-modifying therapies. Clinical trials show TECFIDERA significantly reduces annual relapse rates by 53% compared to placebo.
Biogen (Nasdaq: BIIB) is set to present the EMBARK trial design for its investigational Alzheimer’s therapy, aducanumab, at the 2021 AAN Annual Meeting on April 17, 2021. This Phase 3b, open-label study aims to evaluate the long-term safety and efficacy of aducanumab in Alzheimer’s patients. The presentation will be led by Dr. Carmen Castrillo-Viguera. More details can be accessed on Biogen's investor website, where an archived version will also be available post-event.
Aducanumab, a human monoclonal antibody, has shown promise in slowing cognitive decline in Alzheimer’s disease.
Sage Therapeutics and Biogen announced positive topline results from the Phase 2 KINETIC Study of SAGE-324 for essential tremor treatment. The study achieved its primary endpoint with a significant reduction in upper limb tremor score, showing a 36% decrease in the SAGE-324 group versus 21% in placebo (P=0.049). Severe tremor patients demonstrated an even greater 41% reduction. Safety profiles were consistent with previous data, and plans for further development of SAGE-324 are underway, reflecting the substantial unmet medical need in treating essential tremor affecting over 6.4 million in the U.S.
Biogen (Nasdaq: BIIB) announced the nomination of Dr. Maria C. Freire and William D. Jones for election to its board of directors during the 2021 annual meeting scheduled for June 2, 2021. Dr. Freire, currently with the National Institutes of Health Foundation, and Mr. Jones, CEO of CityLink Investment Corporation, bring diverse backgrounds in public health and business. The company expresses gratitude to retiring director Robert W. Pangia, who has been with the board since 1997. The nominations aim to enhance strategic perspectives and optimize capital allocation for stockholders.
Biogen has entered into a commercialization and license agreement with Bio-Thera Solutions to develop and market BAT1806, a proposed biosimilar referencing ACTEMRA® (tocilizumab). The drug is currently in Phase 3 clinical trials, with ACTEMRA® generating 2.8 billion CHF in sales in 2020. Biogen is set to receive exclusive rights to BAT1806 outside of China, making a $30 million upfront payment subject to trial results. This agreement aims to enhance access to biologic therapies and foster cost savings in healthcare.
Biogen has received marketing authorization from the European Commission for a subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). This new route provides comparable efficacy and safety to the intravenous (IV) formulation while allowing for shorter administration times. The SC option expands treatment access for patients and healthcare providers, particularly during concerns around COVID-19 vaccination. TYSABRI has proven itself over nearly 15 years, with over 213,000 patients treated globally.
Biogen (Nasdaq: BIIB) plans to build a new gene therapy manufacturing facility in Research Triangle Park, North Carolina, with operations expected to commence in 2023. This facility, covering 175,000 square feet, aims to enhance Biogen's gene therapy pipeline across various therapeutic areas and create approximately 90 jobs. The total investment in this facility is projected at $200 million. This investment emphasizes Biogen’s commitment to providing high-quality medicines to patients and fostering a diverse workforce.
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