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 submission of a marketing authorization application (MAA) for lecanemab (LEQEMBI™) to the European Medicines Agency (EMA) for treating early Alzheimer's disease. This application follows positive results from the Phase III Clarity AD study, which demonstrated a significant reduction in clinical decline in patients. The study met its primary endpoint, highlighting the potential of lecanemab in early AD. The companies aim to advance lecanemab's regulatory approval and commercialization globally.
On January 6, 2023, Eisai and Biogen announced the submission of a supplemental Biologics License Application (sBLA) for the traditional approval of LEQEMBI™ (lecanemab-irmb) to the FDA. This follows its previous accelerated approval based on Phase 2 data. The application is supported by the Phase 3 Clarity AD clinical trial, which met primary and secondary endpoints with significant results. Eisai plans to seek approval in Japan and the EU by March 31, 2023, enhancing access to Alzheimer’s treatment. This demonstrates commitment to patients amid ongoing challenges in Alzheimer's research.
The FDA has granted accelerated approval for LEQEMBI™ (lecanemab-irmb), a monoclonal antibody aimed at treating Alzheimer's disease. This decision was based on Phase 2 data indicating a reduction in amyloid-beta plaques in early-stage patients. LEQEMBI is intended for individuals with mild cognitive impairment or mild dementia, with treatment requiring baseline MRI scans and ongoing monitoring for potential side effects like amyloid-related imaging abnormalities (ARIA). Eisai plans a Supplemental Biologics License Application for traditional approval soon.
Biogen has announced the promotion of Priya Singhal, M.D., M.P.H. to Executive Vice President, Head of Development, following a restructuring that separates Research and Development into distinct functions. Dr. Singhal, who was previously Interim Head of R&D, will oversee development programs while a search for a new Executive Vice President, Head of Research, is underway. This strategic move, according to CEO Christopher Viehbacher, aims to enhance productivity and better manage risks and resources, ultimately aiming to deliver innovative therapies for challenging diseases.
Biogen has partnered with Alcyone Therapeutics to develop the ThecaFlex DRx™ System, an implantable device aimed at delivering antisense oligonucleotide therapies for neurological disorders like SMA and ALS. This collaboration includes a $10 million upfront payment and potential milestone payments up to $41 million, contingent on development achievements. The ThecaFlex DRx™ has received CE Mark in Europe and Breakthrough Device Designation from the FDA, paving the way for future clinical studies. Biogen seeks to enhance patient treatment experiences with this innovative delivery method.
Eisai Co., Ltd. and Biogen Inc. have initiated the submission of a Biologics License Application (BLA) for lecanemab to China's National Medical Products Administration (NMPA). This Category 1 drug aims to treat Alzheimer's disease and has shown positive results in clinical trials, including the Phase III Clarity AD study, which met its primary and key secondary endpoints. The submission package includes data from Phase II and III trials with significant efficacy outcomes. Eisai plans to seek additional approvals in Japan and Europe by March 31, 2023.
Biogen (Nasdaq: BIIB) has announced a commercialization agreement with Genentech regarding glofitamab, a bispecific antibody targeting B-cell non-Hodgkin’s lymphoma. Biogen will incur no payment obligations and is set to earn tiered royalties on net sales in the U.S. Glofitamab, currently in development, is designed to activate T-cells to eliminate cancer B cells. Pending regulatory approval, it may become a first-in-class treatment. This collaboration reinforces Biogen's long-standing partnership with Genentech in developing anti-CD20 antibodies.
Biogen Inc. (Nasdaq: BIIB) announced the FDA's acceptance for review of its abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar referencing ACTEMRA® (tocilizumab). This biosimilar is aimed at treating moderate to severe rheumatoid arthritis and is supported by Phase 3 clinical trial data showing equivalent efficacy and safety compared to the reference product. The data was previously presented at the European Congress of Rheumatology and ACR. Biogen holds exclusive rights to BIIB800, excluding China, under an agreement with Bio-Thera Solutions.
Sage Therapeutics and Biogen have completed the NDA submission for zuranolone, a rapid-acting oral treatment for major depressive disorder (MDD) and postpartum depression (PPD). This 14-day treatment aims to provide quicker symptom relief compared to existing therapies. The NDA integrates data from the LANDSCAPE and NEST programs, which included multiple studies in adults with MDD and women with PPD. Zuranolone has received Fast Track and Breakthrough Therapy designations by the FDA, indicating its potential significance in treating depression.
Biogen (Nasdaq: BIIB) announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for tofersen, aimed at treating SOD1-ALS, a rare form of amyotrophic lateral sclerosis affecting approximately 2% of ALS patients. Tofersen is positioned to be the first therapy targeting a genetic cause of ALS. The MAA includes comprehensive results from various clinical trials, including the Phase 3 VALOR study. Tofersen is also under FDA review, with a Prescription Drug User Fee Act action date set for April 25, 2023, as Biogen continues its commitment to ALS research.
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