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) generates frequent news across neurology, rare diseases and immunology, reflecting its role as a biotechnology company focused on serious neurological and genetic conditions. News coverage for BIIB often centers on clinical trial results, regulatory milestones, scientific publications and strategic collaborations that shape the company’s therapeutic portfolio.
Investors and healthcare observers following Biogen news can expect updates on marketed therapies such as SPINRAZA (nusinersen) for 5q spinal muscular atrophy, QALSODY (tofersen) for SOD1-ALS, and LEQEMBI (lecanemab-irmb) for early Alzheimer’s disease, co-developed with Eisai. Recent announcements have included European Commission approval of a high-dose SPINRAZA regimen, long-term QALSODY data published in JAMA Neurology, and multiple LEQEMBI data presentations at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference, including subcutaneous administration and long-term treatment analyses.
Biogen news also highlights its collaborations and pipeline. Examples include joint updates with Stoke Therapeutics on zorevunersen, an investigational antisense oligonucleotide for Dravet syndrome, and a research collaboration with Dayra Therapeutics to discover oral macrocyclic peptides for immunological conditions. In addition, the company regularly issues press releases on scientific conference presentations, regulatory submissions, and its broader ALS and Alzheimer’s research programs.
This BIIB news page aggregates such developments in one place, helping readers track Biogen’s clinical progress, regulatory interactions and research directions over time. For investors, clinicians and researchers, it offers a focused view of how Biogen’s scientific and business activities evolve across its key therapeutic areas.
Biogen (Nasdaq: BIIB) released findings from two real-world studies on health disparities in multiple sclerosis (MS) during MSVirtual2020. The research, from MS PATHS and NARCRMS, reveals significant socio-demographic disparities affecting Black and Hispanic individuals with MS, including higher unemployment and income differences compared to white counterparts. The studies also predict employment status based on disability assessments. Biogen's ongoing development of digital tools aims to enhance treatment decisions and improve patient outcomes.
Biogen Inc. (Nasdaq: BIIB) announced a $10 million investment in OneUnited Bank, the largest Black-owned bank in the U.S., aimed at supporting Black economic empowerment. This deposit represents a growing corporate focus on Black businesses and lenders. OneUnited Bank reports a 100% increase in interest since May 2020, attracting over 50,000 new customers and $50 million in deposits. Biogen's investment aligns with its Diversity, Equity, and Inclusion strategy and may help strengthen underrepresented minority businesses.
Biogen and Eisai announced that the FDA accepted the Biologics License Application (BLA) for aducanumab, an investigational Alzheimer’s treatment, granting it Priority Review. The PDUFA target action date is set for March 7, 2021. If approved, aducanumab would be the first therapy to significantly alter Alzheimer’s disease progression and demonstrate better outcomes through amyloid beta removal. This milestone is seen as a potential paradigm shift in treating dementia, addressing a critical public health issue.
Biogen (Nasdaq: BIIB) has entered a collaboration with Denali Therapeutics to co-develop and co-commercialize Denali's LRRK2 inhibitors for Parkinson's disease. The agreement includes a $560 million upfront payment and a $465 million equity investment from Biogen, along with potential milestone payments exceeding $1 billion. Biogen will share development costs (60% Biogen, 40% Denali) and split profits in the U.S. and China (50/50). Biogen also gains rights to two additional programs using Denali's Transport Vehicle technology for neurodegenerative diseases.
Biogen (Nasdaq: BIIB) will present multiple data from its Alzheimer’s disease (AD) clinical development portfolio at the Alzheimer’s Association International Conference (AAIC) online from July 27-31. Highlights include an encore platform presentation of aducanumab's Phase 3 EMERGE and ENGAGE study results on July 29. Additional presentations will cover gosuranemab (BIIB092) and other investigational therapies aimed at improving AD diagnosis and treatment. The event will enhance understanding of patient needs and healthcare capabilities for AD management.
Biogen Inc. (Nasdaq: BIIB) has appointed Michael McDonnell as Executive Vice President and Chief Financial Officer, effective August 15, 2020. Previously CFO at IQVIA, McDonnell will oversee global finance, IT, and investor relations at Biogen. He succeeds Jeffrey Capello, who will assist in the transition before departing on September 15, 2020. CEO Michel Vounatsos expressed confidence in McDonnell’s strategic financial expertise, highlighting the importance of his role amid Biogen's potential breakthroughs in neuroscience.
Biogen (Nasdaq: BIIB) announced plans for a global Phase 4 clinical study, RESPOND, to assess the efficacy and safety of SPINRAZA in infants and children with spinal muscular atrophy (SMA) who have unmet clinical needs after Zolgensma treatment. The study aims to include 60 participants, with a focus on those exhibiting suboptimal motor function. Previous studies indicated that 4 out of 10 patients treated with Zolgensma proceeded to SPINRAZA. Biogen's ongoing commitment involves generating data to enhance treatment decisions for SMA patients.
On July 13, 2020, the Alzheimer's Clinical Trials Consortium (ACTC), Eisai, and Biogen announced the initiation of a new Phase III study, AHEAD 3-45, for BAN2401, an anti-amyloid beta antibody. This study aims to address preclinical Alzheimer's disease in over 1400 participants across multiple countries, focusing on early intervention to prevent cognitive decline. The study will utilize a rigorous endpoint evaluation, including amyloid and tau PET imaging and cognitive assessments. Results from this trial could provide valuable insights on the timing of anti-amyloid therapy interventions.
Biogen announced positive results from a Phase 1/2 study of tofersen (BIIB067), targeting SOD1 amyotrophic lateral sclerosis (ALS). The study, published in The New England Journal of Medicine, showed proof-of-concept, demonstrating a 36% reduction in SOD1 protein concentration in treated patients. Serious adverse events occurred, including two deaths in the tofersen group. Biogen emphasizes its commitment to ALS research despite past challenges. A Phase 3 study, VALOR, is currently underway to further assess tofersen's efficacy and safety.
Biogen and Eisai have submitted a Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease, to the FDA. This submission includes data from the Phase 3 EMERGE and ENGAGE studies, with a request for Priority Review. If approved, aducanumab would be the first therapy to significantly alter the progression of Alzheimer’s disease by removing amyloid beta. EMERGE showed a 22% reduction in clinical decline compared to placebo at 78 weeks. The FDA has 60 days to accept the application for review.
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