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Biogen Inc. - $BIIB STOCK NEWS

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.

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The FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb), a monthly intravenous (IV) maintenance dose to treat early Alzheimer's Disease (AD). A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI demonstrated continued efficacy in removing toxic protofibrils through Phase 2 and Phase 3 studies. Approval could simplify long-term treatment. Eisai also initiated a rolling submission to the FDA for a subcutaneous autoinjector version. LEQEMBI is approved in the U.S., Japan, China, and South Korea, with additional applications in several other countries.

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Biogen (Nasdaq: BIIB) and Delta Flight Products (DFP) announced a collaboration to enhance air travel for passengers with reduced mobility, focusing on individuals who rely on wheelchairs. Approximately 5.5 million Americans depend on wheelchairs for mobility. The partnership aims to gather insights from community events to develop innovative travel solutions, such as a new airplane seat prototype that allows passengers to use their wheelchairs during flights. The initiative will be showcased at the Cure SMA Annual Conference in Austin, Texas, from June 6-9, 2024. Feedback from these events will help inform future advancements, aiming for more equitable and accessible air travel.

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Biogen has received European Commission approval for QALSODY® (tofersen), a treatment for adults with amyotrophic lateral sclerosis (ALS) linked to a superoxide dismutase 1 gene mutation. This marks the first EU approval targeting a genetic cause of ALS, an ultra-rare form of the disease affecting less than 1,000 people in Europe. The approval is based on a 24-week Phase 3 VALOR study, which showed a 55% reduction in neurofilament light chain levels in treated participants, though primary efficacy results were not statistically significant. Common adverse reactions include pain, fatigue, and increased protein in cerebrospinal fluid. Biogen aims to expedite access across Europe and continues to engage with global regulatory authorities.

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Biogen has announced an agreement to acquire Human Immunology Biosciences (HI-Bio) for $1.15 billion upfront, with potential milestone payments up to $650 million. The acquisition includes felzartamab, an anti-CD38 monoclonal antibody with potential applications in various immune-mediated diseases. Felzartamab has received Breakthrough Therapy and Orphan Drug Designations from the FDA for treating primary membranous nephropathy (PMN) and kidney transplant-related antibody-mediated rejection (AMR). Phase 2 studies have shown promise, with plans to advance to Phase 3. The deal aims to combine HI-Bio's expertise with Biogen's global capabilities to accelerate the development of therapies for rare immune diseases.

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Ionis Pharmaceuticals and Biogen announced the discontinuation of BIIB105 (ION541), an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), based on Phase 1/2 ALSpire study results. Despite demonstrating statistically significant reductions in cerebrospinal fluid ATXN2 protein, BIIB105 did not lower plasma neurofilament light chain (NfL) levels, nor did it impact clinical outcomes such as function, breathing, and strength over a 6-month period. Common adverse events included procedural pain, headache, and fall, with higher discontinuation rates in the BIIB105 group. Further analyses of the data are ongoing, and results will be presented at the European Network to Cure ALS (ENCALS) meeting in June 2024.

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Eisai has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for LEQEMBI (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for early Alzheimer's disease. The BLA leverages data from the Clarity AD Study 301 and aims to allow home or medical facility administration, reducing the need for hospital visits compared to IV administration. LEQEMBI has gained approval in the U.S., Japan, and China, with more submissions pending globally. Concerns include amyloid-related imaging abnormalities (ARIA), which can cause serious side effects. Ongoing studies include AHEAD 3-45 and Tau NexGen for preclinical and dominantly inherited Alzheimer's, respectively.

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Biogen Inc. (Nasdaq: BIIB) released its 2023 Corporate Responsibility Report, highlighting progress in key areas such as access to medicines, workforce diversity, community impact, and environmental sustainability. The report showcases achievements like adding new medicines to the portfolio, expanding access to treatments, increasing workforce diversity, supporting local communities, and enhancing environmental initiatives.

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Biogen receives a positive CHMP opinion for TOFIDENCE™, a biosimilar referencing ROACTEMRA®. The CHMP's positive opinion is based on robust analytical, non-clinical, and clinical data comparing TOFIDENCE™ to ROACTEMRA®. If granted marketing authorization by the EC, TOFIDENCE™ will be used to treat rheumatoid arthritis, juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Biogen's biosimilars portfolio in Europe may see an addition of TOFIDENCE™, offering cost-effective treatment options with a new mechanism of action. The recommendation signifies a step towards providing more patients with high-quality biologic medicines. The positive opinion was supported by analytical, non-clinical, and clinical data, confirming TOFIDENCE™ as a biosimilar to the reference product.
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Eisai and Biogen submit a sBLA for LEQEMBI maintenance dosing for Alzheimer's disease treatment. Fast Track designation sought for SC formulation. LEQEMBI aims to reduce protofibrils' impact on brain injury.
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AbCellera (ABCL) partners with Biogen Inc. (BIIB) to discover antibodies for brain-targeted biotherapeutics in neuroscience. The collaboration aims to address the challenge of delivering biologics across the blood-brain barrier. AbCellera will receive upfront payment, milestone payments, and potential royalties on future product sales.
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FAQ

What does Biogen Inc. specialize in?

Biogen focuses on discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases.

Where is Biogen headquartered?

Biogen is headquartered in Cambridge, Massachusetts, with research operations in Zug, Switzerland.

What are some of Biogen's key products?

Key products include treatments for multiple sclerosis like Avonex, Tysabri, Tecfidera, and Vumerity, as well as Spinraza for spinal muscular atrophy and Leqembi for Alzheimer's disease.

How many employees does Biogen have?

Biogen employs approximately 7,000 people worldwide.

What recent acquisitions has Biogen made?

Biogen recently acquired Human Immunology Biosciences for $1.15 billion to expand its immunology pipeline.

What are Biogen’s latest research initiatives?

Biogen is researching treatments for Alzheimer’s, Parkinson’s, and ALS, with several drug candidates in phase 3 trials.

How is Biogen improving travel for people with mobility issues?

Biogen is collaborating with Delta Flight Products to develop solutions that enhance air travel for passengers with reduced mobility.

What is Biogen’s approach to corporate responsibility?

Biogen’s corporate responsibility strategy focuses on sustainable practices and social good, detailed in its 2023 Corporate Responsibility Report.

What is Leqembi and what is its significance?

Leqembi is a treatment for Alzheimer’s disease developed in collaboration with Eisai. It is currently under review by the FDA for monthly maintenance dosing.

Where can I find more information about Biogen?

More information is available on Biogen's official website at www.biogen.com.

Biogen Inc.

Nasdaq:BIIB

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33.73B
144.82M
0.69%
92.98%
2.44%
Biological Product (except Diagnostic) Manufacturing
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