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 (Nasdaq: BIIB) and Eisai announced FDA's accelerated approval of ADUHELM (aducanumab-avwa) for Alzheimer’s treatment, the first to target amyloid beta plaques. Based on clinical trials, ADUHELM demonstrated a 59% to 71% reduction in plaques after 18 months. Approval is contingent on confirmatory trials verifying clinical benefits. The safety profile showed 41% of patients experienced Amyloid Related Imaging Abnormalities (ARIA). Biogen plans to conduct further trials to confirm the drug's efficacy.
Biogen announced positive results from its Phase 3 clinical trial of BAT1806, a biosimilar of ACTEMRA, indicating equivalent efficacy and safety in patients with moderate-to-severe rheumatoid arthritis. The study achieved its primary endpoint, demonstrating a comparable safety profile and pharmacokinetics to the reference drug. Global sales of ACTEMRA were reported at 2.8 billion CHF in 2020. Following these results, Biogen will pay Bio-Thera Solutions $30 million, with potential milestone payments pending. Biosimilars aim to provide cost savings and improve patient access to treatments.
Biogen and Ginkgo Bioworks have announced a collaboration to enhance AAV (adeno-associated virus) production for gene therapies. This partnership will leverage Ginkgo’s synthetic biology expertise to address current manufacturing challenges, potentially accelerating Biogen’s gene therapy pipeline. Ginkgo will receive an upfront payment of $5 million, along with the possibility of $115 million in milestone payments. The collaboration aims to optimize AAV production efficiency, which is crucial for treating neurological and neuromuscular diseases.
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.
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