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.
Alcyone Therapeutics has received FDA approval to continue enrollment in the PIERRE pivotal IDE clinical study for the ThecaFlex DRx™ System. This implantable device is being investigated for routine subcutaneous administration of nusinersen to treat spinal muscular atrophy (SMA). The first stage, involving 10 SMA patients, has been completed with no device-related adverse events. The FDA has approved enrollment of an additional 80 SMA patients across 30 centers in the U.S. and Europe.
Key observations include:
- Implantation duration: 1-2 hours
- Hospital discharge: Within 24 hours
- Infusion procedure: Less than 30 minutes
- Actual nusinersen infusion: Less than 10 minutes
The ThecaFlex system aims to provide a less invasive, more accessible alternative to repeat lumbar puncture for SMA patients receiving SPINRAZA® (nusinersen) therapy.
Eisai and Biogen presented new clinical data for LEQEMBI® (lecanemab-irmb) at AAIC 2024, showing continued benefits for early Alzheimer's disease patients after three years of treatment. Key findings include:
- 51% of patients with no/low tau showed improved cognition and function over 3 years
- Lecanemab's dual action on protofibrils and plaques slows tau spread across all brain regions
- Three years of treatment reduced clinical decline by -0.95 on CDR-SB scale
- Safety profile remained consistent with no new concerns over 3 years
- Biomarker data suggests AD continues progressing after plaque clearance, supporting continued treatment
The results indicate lecanemab provides ongoing clinically meaningful benefits for early AD patients through its unique dual mechanism targeting toxic protofibrils and plaques.
Biogen (BIIB), Beckman Coulter, and Fujirebio have announced a collaboration to develop blood-based biomarkers and tests for tau pathology in Alzheimer's disease (AD). The partnership aims to create accessible, minimally invasive tools to stratify patients and monitor treatment response for future therapies targeting tau pathology in AD.
The collaboration will leverage Biogen's expertise in biomarker research and clinical study data, while Fujirebio and Beckman Coulter will handle diagnostic development, manufacturing, and commercialization. These tau-specific blood-based biomarkers could provide critical insights into AD's pathological processes and potentially accelerate the development of new therapies.
Eisai and Biogen announced that the European Medicines Agency's CHMP has adopted a negative opinion on the Marketing Authorization Approval for lecanemab, their Alzheimer's disease (AD) treatment. This decision is a setback for the companies in the European market, where 6.9 million people are affected by AD, with numbers expected to double by 2050. Lecanemab is already approved in several countries, including the US, Japan, and China. Eisai plans to seek re-examination of the CHMP opinion to make the treatment available in the EU. The companies remain committed to addressing the unmet need in early AD treatment, emphasizing the significance of targeting underlying causes of disease progression.
Sage Therapeutics and Biogen announced disappointing topline results from their Phase 2 KINETIC 2 study of SAGE-324 (BIIB124) for treating essential tremor (ET). The study failed to demonstrate a statistically significant dose-response relationship or any significant differences between SAGE-324 doses and placebo in reducing tremor severity. Key findings include:
- No statistically significant improvements in the primary endpoint (TETRAS Performance Subscale Item 4 total score) or secondary endpoint (TETRAS Activities of Daily Living Composite Score)
- 147 participants were randomized to placebo, 15 mg, 30 mg, or 60 mg doses
- Common side effects included somnolence, dizziness, and fatigue
- Dose-related increases in CNS depressant side effects were observed
As a result, Sage and Biogen will discontinue further clinical development of SAGE-324 for essential tremor.
Biogen (Nasdaq: BIIB) has finalized its acquisition of Human Immunology Biosciences (HI-Bio), a clinical-stage biotech firm focused on targeted therapies for severe immune-mediated diseases (IMDs). This acquisition brings the promising late-stage therapeutic candidate felzartamab into Biogen’s pipeline. Felzartamab has shown positive interim results in Phase 2 trials for IgA nephropathy (IgAN) and antibody-mediated rejection (AMR), and proof-of-concept in primary membranous nephropathy (PMN). Biogen aims to advance felzartamab to Phase 3 trials for these indications, bolstering its immunology portfolio.
Key figures from both companies expressed enthusiasm about the merger, highlighting shared values and a commitment to innovative treatments for patients with unmet needs.
On June 27, 2024, Eisai and Biogen announced the launch of the Alzheimer's drug LEQEMBI® (lecanemab) in China, marking the third country to launch the drug after the U.S. and Japan. LEQEMBI received approval in January 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD). The drug, which binds to and reduces soluble and insoluble amyloid-beta aggregates, is the first approved treatment shown to slow disease progression and cognitive decline.
With an estimated 17 million early AD patients in China, Eisai is focusing on early diagnosis and treatment through medical representatives and collaborations with health insurance companies, private health checkups, and nursing homes. The company is also working on building an early AD diagnosis pathway using online and offline services, including the "Yin Fa Tong" online health platform. Initially, LEQEMBI will be available in the private market, supported by a new healthcare insurance plan covering part of the drug cost.
Biogen announced that the European Commission has approved TOFIDENCE™, a biosimilar monoclonal antibody referencing ROACTEMRA®. This approval covers its use for treating moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
TOFIDENCE's approval is based on extensive analytical, non-clinical, and clinical data, demonstrating its comparability to the reference product. Clinical trials confirmed its similar pharmacokinetic, safety, and efficacy profiles.
This addition enhances Biogen's immunology biosimilars portfolio, aiming to provide more treatment options and potential cost savings in European healthcare systems.
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.
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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