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 the initiation of a submission to Japan's PMDA for lecanemab (BAN2401), an investigational antibody for Alzheimer's disease. The submission aims to utilize the 'prior assessment consultation' process to expedite application review. Eisai has submitted non-clinical data and plans to file for manufacturing and marketing approval in Japan during fiscal year 2022, contingent on data from the ongoing Clarity AD Phase 3 study expected in fall 2022. This follows a rolling submission to the U.S. FDA for lecanemab under the Accelerated Approval pathway.
Sage Therapeutics and Biogen announced that their CORAL Study achieved both primary and secondary endpoints in treating major depressive disorder (MDD) with zuranolone 50 mg. The trial demonstrated a statistically significant reduction in depressive symptoms at Day 3 and over a 2-week period compared to placebo. Participants reported adverse effects mostly mild or moderate, with no new safety signals. The results suggest zuranolone may accelerate the efficacy of existing antidepressants. A conference call will discuss the findings further.
Biogen and Xbrane Biopharma AB have entered a commercialization agreement to develop Xcimzane™, a proposed biosimilar referencing CIMZIA®, indicated for conditions such as rheumatoid arthritis and psoriasis. CIMZIA® generated €1.8 billion in 2020 sales. Biogen will handle global rights and make an upfront payment of $8 million to Xbrane, with potential milestones reaching $80 million. This collaboration aims to increase patient access to affordable treatments while bolstering Biogen's biosimilar pipeline.
Biogen has opted to participate in the development of mosunetuzumab, a bispecific antibody for treating B-cell non-Hodgkin’s lymphoma, by paying a $30 million option fee to Genentech. This investigational therapy targets CD20 and CD3, having received Breakthrough Therapy Designation from the FDA for adult patients with relapsed/refractory follicular lymphoma. Biogen will share in the operating profits in the low to mid 30% range and is eligible for royalties outside the U.S. Additionally, mosunetuzumab is in trials for systemic lupus erythematosus.
Biogen (Nasdaq: BIIB) announces the retirement of Board members Nancy Leaming and Brian Posner, effective at the 2022 annual meeting. Leaming, with a background in healthcare insurance, and Posner, a private investor, have served on the Board since 2008. Their contributions have been vital in guiding Biogen's mission in developing therapies for neurological diseases. The leadership expressed gratitude for their service, emphasizing the company's ongoing commitment to innovation in neuroscience and addressing climate health issues.
Biogen Inc. (Nasdaq: BIIB) has finalized a deal with Samsung Biologics for the sale of its equity stake in the Samsung Bioepis joint venture for up to $2.3 billion. This includes an immediate cash payment of $1 billion and deferred payments totaling $1.25 billion over two years. Biogen will maintain commercial rights for certain biosimilars, including BYOOVIZ and an investigational candidate, SB15. This move is viewed as a significant step in continuing Biogen's portfolio and enhancing financial flexibility.
Biogen and Eisai announced details of the ENVISION Phase 4 study of ADUHELM for early Alzheimer’s disease, aiming for 1,500 participants, inclusive of 18% from Black/African American and Latinx backgrounds. This initiative emphasizes diversity in clinical trials, essential for relevant data. The study's primary endpoint will assess cognitive function after 18 months, utilizing CDR-SB. While the trial progresses, Biogen faces potential Medicare coverage restrictions for ADUHELM. The patient screening is set to begin in May 2022.
Biogen has exercised its option to obtain a worldwide, exclusive license for BIIB115, a preclinical investigational antisense oligonucleotide aimed at treating spinal muscular atrophy (SMA). This includes a $60 million upfront payment to Ionis Pharmaceuticals. BIIB115 is intended to address unmet needs in SMA treatment and has potential for extended dosing intervals. Biogen will handle all development costs, including future milestone payments and royalties on net sales. BIIB115 may significantly enhance treatment options for SMA patients.
Biogen and Ionis Pharmaceuticals announced a strategic collaboration whereby Biogen exercised its option to acquire a worldwide, exclusive license to develop and commercialize BIIB115/ION306, an investigational antisense oligonucleotide targeting spinal muscular atrophy (SMA). This initiative aims to address unmet patient needs and is supported by a $60 million upfront payment from Biogen. Plans include advancing BIIB115 into clinical trials to evaluate its safety and efficacy, with Biogen handling all development costs.
On December 23, 2021, Eisai and Biogen announced that their investigational Alzheimer's treatment, lecanemab, received Fast Track designation from the U.S. FDA. This designation aims to expedite development for drugs addressing serious conditions. Lecanemab has previously been granted Breakthrough Therapy designation in June 2021. The ongoing Phase 3 Clarity AD study includes 1,795 patients, with results expected to confirm clinical benefits. Lecanemab targets amyloid-beta aggregates, showing promise in reducing clinical decline based on Phase 2 results.
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