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 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.
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.
Abarca, a pharmacy benefit manager, announced a value-based agreement with Biogen (NASDAQ: BIIB) for drugs Avonex® and Tecfidera®, aimed at improving outcomes for Medicaid patients in Puerto Rico. This collaboration, initiated in 2017, represents the first publicly disclosed value-based agreement for Medicaid populations. Abarca's president emphasized that such contracts are vital for future pharmacy benefits, and Biogen's president expressed commitment to connecting real-world outcomes with therapy costs.
Samsung Bioepis and Biogen announced that the European Medicines Agency (EMA) has accepted their Marketing Authorisation Application for SB11, a proposed biosimilar of Lucentis (ranibizumab), targeting retinal vascular disorders. This application acceptance highlights their collaboration toward providing affordable treatment options. If approved, SB11 will enhance Biogen's biosimilar portfolio, supporting financial sustainability in healthcare. The collaboration aims to address pressing health needs and ensure patient access to essential therapies.
Biogen (Nasdaq: BIIB) has announced the launch of the Healthy Climate, Healthy Lives™ initiative, a $250 million, 20-year plan to eliminate fossil fuels from its operations by 2040. This initiative includes collaborations with leading institutions like MIT and Harvard to mitigate the health impacts of fossil fuels. Biogen aims to power operations with renewable energy, transition its fleet to electric vehicles, and support suppliers in reducing fossil fuel usage. This commitment positions Biogen as the first Fortune 500 company to strive for complete fossil fuel independence.
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