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.
On November 17, 2021, Biogen and Eisai announced a negative trend vote regarding their Marketing Authorization Application for aducanumab (100 mg/mL) for Alzheimer’s treatment by the European Medicines Agency's CHMP. Following an oral explanation, a formal opinion is expected by December 16, 2021. Biogen emphasized its belief in the data supporting aducanumab, citing new Phase 3 findings that suggest it effectively reduces amyloid beta plaques. The drug is already approved in the U.S. under accelerated conditions, pending further confirmatory trials.
Biogen has received marketing authorization from the European Commission for VUMERITY (diroximel fumarate), a next-generation oral treatment for adults with relapsing-remitting multiple sclerosis (MS). The approval builds on Biogen's reputation in MS therapies and follows similar authorizations in the U.S., Great Britain, and Switzerland. Data from Phase 3 trials indicate that VUMERITY has a favorable gastrointestinal tolerability profile, resulting in lower discontinuation rates compared to TECFIDERA. The launch aims to provide patients flexibility in treatment adherence amid the ongoing COVID-19 pandemic.
Biogen (Nasdaq: BIIB) announced that Dr. Alfred Sandrock, Head of Research & Development, will retire on December 31, 2021, after 23 years with the company. He has spearheaded the development of key therapies such as Tysabri, Tecfidera, Spinraza, and Aduhelm. Priya Singhal will serve as interim Head of Research & Development until a permanent successor is found. Biogen's CEO and Board acknowledged Dr. Sandrock's significant contributions, emphasizing his impact on R&D and the company's growth.
Biogen and Eisai announced significant findings from ADUHELM's Phase 3 trials at the CTAD conference. Analysis of over 7,000 plasma samples revealed that ADUHELM notably lowered plasma p-tau181, a biomarker for tau tangles in Alzheimer's, in a dose- and time-dependent manner compared to placebo. The reduction in p-tau181 correlated with decreased amyloid beta plaque and less cognitive decline, supporting ADUHELM's efficacy. The EMERGE high-dose group showed a 13% decrease in p-tau181, while ENGAGE showed a 16% decrease. These results strengthen the case for ADUHELM as a treatment option in early Alzheimer's disease.
Eisai and Biogen have announced the use of plasma-based biomarkers in their Phase 3 AHEAD 3-45 clinical trial for lecanemab, an investigational treatment for Alzheimer's disease. This innovative approach aims to improve screening efficiency by identifying cognitively unimpaired individuals eligible for PET imaging. Results from 659 participants indicate that the Aβ42/40 ratio accurately predicts PET eligibility (AUC of 0.87). The trial, which began in July 2020, is pivotal for early Alzheimer's research and was presented at the CTAD conference.
Eisai Co., Ltd. and Biogen Inc. presented positive results from sensitivity analyses of lecanemab at the CTAD conference, demonstrating consistent efficacy for patients with early Alzheimer's disease (AD). Lecanemab outperformed placebo in several key assessments including the Alzheimer’s Disease Composite Score (ADCOMS). The Phase 2b trial achieved super-superiority in clinical change and identified an effective dosing strategy. The companies continue to advance lecanemab through ongoing studies, seeking regulatory approval under the FDA's accelerated pathway.
Eisai and Biogen presented new findings on lecanemab, an investigational treatment for early Alzheimer's disease, at the CTAD conference on November 9-12, 2021. The results from the Phase 2b study and the open-label extension indicated significant reductions in brain amyloid levels within three months, with over 80% of participants achieving amyloid negative status by 12-18 months. The study suggests a potential disease-modifying effect of lecanemab, maintaining clinical benefits even after temporary treatment discontinuation. Additionally, lecanemab exhibited a favorable safety profile, with low incidence of ARIA-E.
Biogen (BIIB) announced it will present new data on ADUHELM at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference from November 9-12, 2021. Highlighting the largest dataset in early Alzheimer’s research with over 3,000 patients, a late-breaking presentation will focus on ADUHELM's effect on plasma phosphorylated tau181 reduction, correlating with amyloid beta plaques and clinical decline. Additionally, data from the EMBARK trial will be discussed, examining the impact of stopping treatment on disease progression. The findings aim to advance understanding and treatment decisions in Alzheimer's disease.
Sage Therapeutics and Biogen announced plans to submit a New Drug Application (NDA) for the investigational drug zuranolone aimed at treating Major Depressive Disorder (MDD) in the second half of 2022. Following successful discussions with the FDA, their filing will include data from key clinical studies. A subsequent NDA for Postpartum Depression (PPD) is anticipated in early 2023. Both companies aim to launch marketing for zuranolone upon FDA approval, presenting a potential solution for millions suffering from depression worldwide.
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