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 announced key findings from its multiple sclerosis therapies at the ECTRIMS virtual meeting on October 13-15, 2021. The Phase 3b NOVA study showed that every six-week dosing of TYSABRI (natalizumab) maintains efficacy similar to the four-week regimen, with 96.9% relapse-free patients at 72 weeks. A real-world analysis revealed lower relapse risk with TYSABRI compared to Ocrevus (ocrelizumab). Additionally, new data from the EVOLVE-MS-2 study confirmed favorable gastrointestinal tolerability for VUMERITY (diroximel fumarate) during dose titration, potentially enhancing treatment compliance.
Biogen (Nasdaq: BIIB) released findings from the MS PATHS study indicating that 100% of multiple sclerosis (MS) patients treated with natalizumab, interferons, or fumarates generated an antibody response after COVID-19 vaccination. However, only about 40% of those using anti-CD20 and S1P therapies showed similar responses. This analysis, based on data from 322 participants, highlights the varying impacts of MS disease-modifying therapies (DMTs) on vaccine efficacy. Biogen is presenting additional findings at the ECTRIMS virtual meeting from October 13-15, 2021.
Sage Therapeutics and Biogen announced promising data from their clinical programs for zuranolone, targeting major depressive disorder (MDD) and postpartum depression (PPD). Results from the Phase 3 WATERFALL Study showed significant reductions in depressive symptoms, with improvements observed as early as Day 3. Safety profiles were favorable, showing no common side effects linked to current antidepressants. A conference call is scheduled for October 4, 2021, to discuss findings presented at the ECNP Congress.
Eisai Co., Ltd. and Biogen have initiated a rolling submission of a Biologics License Application (BLA) for lecanemab (BAN2401) to the U.S. FDA, targeting early Alzheimer's disease. This application leverages data from a Phase 2b trial showing significant amyloid plaque reduction and decreased clinical decline. The submission is under the accelerated approval pathway, following a Breakthrough Therapy designation for lecanemab. The ongoing Phase 3 Clarity AD trial will serve as a confirmatory study once results are available.
Biogen (Nasdaq: BIIB) hosted a virtual Investor R&D Day to showcase its extensive neuroscience pipeline, featuring 33 clinical programs, with 12 in Phase 3. Key highlights include ADUHELM, the first Alzheimer’s therapy in 20 years, and lecanemab, a promising therapy in Phase 3 for early Alzheimer’s. Biogen is also advancing zuranolone for major depressive disorder, Tofersen for ALS, and therapies for stroke and lupus. The company emphasizes its innovative capabilities in neuroscience, aiming to transform treatment standards in high unmet need areas.
BYOOVIZ™ has made history as the first ophthalmology biosimilar approved by the FDA in the United States. This biosimilar, referencing LUCENTIS®, targets conditions like neovascular age-related macular degeneration and macular edema. Approximately 11 million individuals in the U.S. suffer from AMD, and BYOOVIZ™ aims to enhance patient access to affordable treatments. With over $100 billion in projected savings from biosimilars in the next five years, this approval marks a crucial advancement for retinal treatment options, reinforcing Biogen's commitment to improving healthcare accessibility.
Biogen (NASDAQ: BIIB) announced a positive opinion from the CHMP for VUMERITY, a next-generation oral fumarate for relapsing-remitting multiple sclerosis (RRMS). The Phase 3 EVOLVE-MS-2 study demonstrated low treatment discontinuation rates due to gastrointestinal tolerability, with VUMERITY at 1.6% compared to 6% for TECFIDERA. This new oral medication aims to support MS patients, especially during the COVID-19 pandemic. VUMERITY is already the top prescribed oral MS therapy in the U.S. and highlights Biogen's commitment to addressing treatment challenges in the MS community.
Biogen announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational drug for small fiber neuropathy (SFN). The 200 mg twice daily dose met its primary endpoint, showing significant reduction in average daily pain compared to placebo. However, the 350 mg dose did not meet its primary endpoint but indicated improvement in patient-reported outcomes. Both doses were generally well tolerated. Biogen plans to analyze CONVEY data further and continue developing vixotrigine for chronic neuropathic pain, addressing a significant unmet medical need.
Biogen has announced the initiation of the ASCEND Phase 3b clinical study to evaluate a higher dose of nusinersen in patients with later-onset spinal muscular atrophy (SMA) who have been previously treated with Evrysdi. The study aims to address unmet treatment needs and enhance patient outcomes. The protocol has been submitted to the U.S. FDA and plans to enroll up to 135 participants over approximately 2.5 years. Participants will receive two loading doses followed by maintenance doses while assessing efficacy through various clinical measures.
Biogen has announced results from the Phase 3b NOVA study, which evaluated the efficacy of a six-week dosing schedule of natalizumab (TYSABRI) for multiple sclerosis patients. The study, involving 499 participants, indicated a non-clinically meaningful difference in controlling disease activity compared to the approved four-week regimen. Although a reduction in the probability of progressive multifocal leukoencephalopathy (PML) was reported, safety profiles remained consistent. Further analysis is ongoing, with detailed results expected to be published in a scientific forum.