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 and Biogen announced that the FDA accepted the Biologics License Application for lecanemab, aimed at treating early Alzheimer's disease. The application, submitted in May 2022, received Priority Review, with a PDUFA action date set for January 6, 2023. The ongoing Clarity AD Phase 3 clinical study has enrolled 1,795 patients, with primary endpoint results anticipated in Fall 2022. Lecanemab is a monoclonal antibody designed to target amyloid beta aggregates, representing a potential new treatment option for those affected by Alzheimer's.
Biogen (NASDAQ: BIIB) has announced a collaboration with Happify Health to enhance digital support for individuals living with Multiple Sclerosis (MS). Through this partnership, the AI-powered platform will provide MS patients with educational resources, treatment options, and community connections to improve their overall well-being. Happify Health’s approach combines digital therapeutics with expert consultations, tailored to the needs of MS patients. This collaboration signifies Biogen's commitment to advancing digital health in the MS treatment landscape.
Biogen Inc. (Nasdaq: BIIB) announced that the European Patent Office granted a patent for TECFIDERA (dimethyl fumarate), expiring in February 2028. This patent supports the approved dosing regimen of 480mg per day for treating multiple sclerosis, as recommended by the European Medicines Agency. TECFIDERA is the most prescribed oral medication for relapsing forms of MS globally, with over 560,000 patients treated, accumulating more than 1.1 million patient-years of exposure. Patent details are expected to be published in the European Patent Bulletin soon.
Biogen (Nasdaq: BIIB) is actively enrolling studies addressing unmet needs in spinal muscular atrophy (SMA). Recent findings from the RESPOND study indicate infants and toddlers face residual medical issues post-gene therapy Zolgensma. SPINRAZA treatment has shown good tolerability, with safety data from DEVOTE supporting the development of a higher dose of nusinersen. Biogen's commitment to SMA research includes continued investment in ongoing studies, aiming to enhance therapeutic options for patients and improve clinical outcomes.
Biogen has entered a collaboration with Alectos Therapeutics to develop AL01811, a preclinical selective GBA2 inhibitor with potential as an oral treatment for Parkinson's Disease (PD). This agreement includes a $15 million upfront payment to Alectos and eligibility for up to $707.5 million in future milestone payments. Currently, no approved disease-modifying therapies exist for PD, affecting 10 million patients globally. Biogen aims to advance therapies for movement disorders that enhance patient quality of life.
Biogen and Bio-Thera Solutions announced promising Phase 3 results for BIIB800, a biosimilar to ACTEMRA. The trial involved 621 patients with moderate to severe rheumatoid arthritis, demonstrating comparable efficacy, safety, and immunogenicity between BIIB800 and the reference product. Key metrics showed ACR20 response rates of 68.97% for BIIB800 versus 64.82% for ACTEMRA at week 12, and 69.89% versus 67.94% at week 24. The data highlights Biogen's commitment to biosimilars, aiming to enhance patient access to essential treatments.
Biogen announced new 12-month data for tofersen, an investigational drug for SOD1-ALS, showing earlier initiation slowed declines in clinical, respiratory, and muscle functions, along with improving quality of life. The analysis, based on the Phase 3 VALOR study, indicated that early initiation may lower the risk of death or permanent ventilation, with robust reductions in neurofilament levels, marking significant neurodegenerative impacts. Despite not meeting primary endpoints in earlier trials, the data suggest potential meaningful benefits for SOD1-ALS patients.
Sage Therapeutics and Biogen announced successful results from the Phase 3 SKYLARK Study of zuranolone, an oral treatment for postpartum depression (PPD). The study achieved its primary endpoint, showing a statistically significant improvement in depressive symptoms at Day 15 with a change from baseline HAMD-17 total score of -15.6 for zuranolone compared to -11.6 for placebo (p=0.0007). Additionally, safety profiles were consistent with previous studies. Zuranolone aims to provide rapid relief for the one in eight women affected by PPD in the U.S.
Eisai and Biogen announced the completion of a rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab (BAN2401), an investigational treatment for mild cognitive impairment due to Alzheimer's disease. The submission is under the accelerated approval pathway, with a request for Priority Review. The Phase 3 Clarity AD trial, involving 1,795 patients, is expected to report results in Fall 2022 and will serve as confirmatory evidence for lecanemab's clinical benefits. The BLA is supported by extensive safety and efficacy data from earlier trials.
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