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.
On January 15, 2023, Eisai Co., Ltd. and Biogen Inc. announced the submission of a marketing authorization application for lecanemab to treat mild cognitive impairment and early Alzheimer's disease in Japan. This follows positive Phase III clinical trial results showing significant reductions in clinical decline among patients. Lecanemab, known as LEQEMBI™ in the U.S., received accelerated FDA approval earlier in January 2023. However, common adverse effects include infusion reactions and amyloid-related imaging abnormalities. Eisai leads global development while both companies co-promote the drug.
Eisai Co., Ltd. and Biogen Inc. announced the submission of a marketing authorization application (MAA) for lecanemab (LEQEMBI™) to the European Medicines Agency (EMA) for treating early Alzheimer's disease. This application follows positive results from the Phase III Clarity AD study, which demonstrated a significant reduction in clinical decline in patients. The study met its primary endpoint, highlighting the potential of lecanemab in early AD. The companies aim to advance lecanemab's regulatory approval and commercialization globally.
On January 6, 2023, Eisai and Biogen announced the submission of a supplemental Biologics License Application (sBLA) for the traditional approval of LEQEMBI™ (lecanemab-irmb) to the FDA. This follows its previous accelerated approval based on Phase 2 data. The application is supported by the Phase 3 Clarity AD clinical trial, which met primary and secondary endpoints with significant results. Eisai plans to seek approval in Japan and the EU by March 31, 2023, enhancing access to Alzheimer’s treatment. This demonstrates commitment to patients amid ongoing challenges in Alzheimer's research.
The FDA has granted accelerated approval for LEQEMBI™ (lecanemab-irmb), a monoclonal antibody aimed at treating Alzheimer's disease. This decision was based on Phase 2 data indicating a reduction in amyloid-beta plaques in early-stage patients. LEQEMBI is intended for individuals with mild cognitive impairment or mild dementia, with treatment requiring baseline MRI scans and ongoing monitoring for potential side effects like amyloid-related imaging abnormalities (ARIA). Eisai plans a Supplemental Biologics License Application for traditional approval soon.
Biogen has announced the promotion of Priya Singhal, M.D., M.P.H. to Executive Vice President, Head of Development, following a restructuring that separates Research and Development into distinct functions. Dr. Singhal, who was previously Interim Head of R&D, will oversee development programs while a search for a new Executive Vice President, Head of Research, is underway. This strategic move, according to CEO Christopher Viehbacher, aims to enhance productivity and better manage risks and resources, ultimately aiming to deliver innovative therapies for challenging diseases.
Biogen has partnered with Alcyone Therapeutics to develop the ThecaFlex DRx™ System, an implantable device aimed at delivering antisense oligonucleotide therapies for neurological disorders like SMA and ALS. This collaboration includes a $10 million upfront payment and potential milestone payments up to $41 million, contingent on development achievements. The ThecaFlex DRx™ has received CE Mark in Europe and Breakthrough Device Designation from the FDA, paving the way for future clinical studies. Biogen seeks to enhance patient treatment experiences with this innovative delivery method.
Eisai Co., Ltd. and Biogen Inc. have initiated the submission of a Biologics License Application (BLA) for lecanemab to China's National Medical Products Administration (NMPA). This Category 1 drug aims to treat Alzheimer's disease and has shown positive results in clinical trials, including the Phase III Clarity AD study, which met its primary and key secondary endpoints. The submission package includes data from Phase II and III trials with significant efficacy outcomes. Eisai plans to seek additional approvals in Japan and Europe by March 31, 2023.
Biogen (Nasdaq: BIIB) has announced a commercialization agreement with Genentech regarding glofitamab, a bispecific antibody targeting B-cell non-Hodgkin’s lymphoma. Biogen will incur no payment obligations and is set to earn tiered royalties on net sales in the U.S. Glofitamab, currently in development, is designed to activate T-cells to eliminate cancer B cells. Pending regulatory approval, it may become a first-in-class treatment. This collaboration reinforces Biogen's long-standing partnership with Genentech in developing anti-CD20 antibodies.
Biogen Inc. (Nasdaq: BIIB) announced the FDA's acceptance for review of its abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar referencing ACTEMRA® (tocilizumab). This biosimilar is aimed at treating moderate to severe rheumatoid arthritis and is supported by Phase 3 clinical trial data showing equivalent efficacy and safety compared to the reference product. The data was previously presented at the European Congress of Rheumatology and ACR. Biogen holds exclusive rights to BIIB800, excluding China, under an agreement with Bio-Thera Solutions.
Sage Therapeutics and Biogen have completed the NDA submission for zuranolone, a rapid-acting oral treatment for major depressive disorder (MDD) and postpartum depression (PPD). This 14-day treatment aims to provide quicker symptom relief compared to existing therapies. The NDA integrates data from the LANDSCAPE and NEST programs, which included multiple studies in adults with MDD and women with PPD. Zuranolone has received Fast Track and Breakthrough Therapy designations by the FDA, indicating its potential significance in treating depression.
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