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.
Eisai and Biogen presented preliminary results from the Phase 2b study of lecanemab (BAN2401), an investigational treatment for Alzheimer's disease, at the AAIC. After 18 months of treatment, lecanemab demonstrated a reduction in brain amyloid and slowed clinical decline in early Alzheimer's patients. The clinical effects remained significant even during an off-treatment gap. These findings suggest a potential disease-modifying effect of lecanemab. Ongoing research includes the Phase 3 Clarity AD study, with results expected by September 2022.
Biogen announced the launch of the ICARE AD-US study, a Phase 4 observational study evaluating the safety and effectiveness of ADUHELM in clinical practice. The study aims to enroll at least 16% of participants from Black/African American and Latinx communities, addressing underrepresentation in Alzheimer’s trials. With 6,000 participants expected over four years, the study will monitor long-term outcomes. Biogen stresses the importance of generating new data on ADUHELM while ensuring diverse patient representation to understand treatment impacts better.
Biogen and Ionis Pharmaceuticals reported positive topline data from a Phase 1b clinical trial of BIIB080, aimed at treating mild Alzheimer's disease. The trial demonstrated significant dose-dependent reductions in tau protein levels in cerebrospinal fluid, achieving mean reductions of 30% to 49% across various dosing schedules. All participants completed the treatment phases, with no serious adverse events reported. These findings underscore the potential of BIIB080 and Ionis' antisense technology in addressing neurodegenerative diseases, paving the way for further clinical investigations.
Biogen (Nasdaq: BIIB) presented new data on ADUHELM™ at the Alzheimer’s Association International Conference. Key findings from the EMERGE trial indicate that high-dose aducanumab treatment significantly slows cognitive, functional, and behavioral decline in early Alzheimer’s disease. Data included correlations between amyloid beta reductions and clinical decline, supporting the drug's efficacy. ADUHELM's accelerated FDA approval necessitates verification of clinical benefits in ongoing studies. The company aims to engage with the dementia research community through these findings.
Biogen (Nasdaq: BIIB) announced its participation at the Alzheimer’s Association International Conference (AAIC) from July 26-30, 2021, featuring multiple presentations on its Alzheimer's disease portfolio, including ADUHELM (aducanumab-avwa). This drug, recently granted FDA accelerated approval, is aimed at treating mild cognitive impairment and mild dementia, showing promise in reducing amyloid beta plaques. Biogen will present new analyses from several studies and lead a late-breaking presentation on the real-world observational Phase 4 study, ICARE AD-US, to assess ADUHELM's long-term effectiveness.
Biogen's ADUHELM, the first Alzheimer’s treatment approved since 2003, targets amyloid plaques in the brain. Approved by the FDA on June 7, 2021, the drug's effectiveness is based on clinical trials involving over 3,000 patients and substantial documentation. Despite criticisms regarding its approval process, Biogen emphasizes the importance of providing treatment options to patients. ADUHELM's approval has renewed investment in Alzheimer’s research, with the company committed to ensuring transparency and collaboration with regulatory agencies.
Mirimus announced a collaboration with Biogen (NASDAQ: BIIB) aimed at developing RNAi therapeutics for various neurological diseases. The specifics of this strategic partnership are undisclosed, but Mirimus will leverage its expertise in RNAi and CRISPR technologies to create potential therapeutics. If the feasibility of these treatments is confirmed, further pre-clinical development could follow. This collaboration expands Mirimus's role in therapeutic development, building on its previous successes in creating animal models and advancing COVID-19 testing methods.
Biogen and InnoCare Pharma have announced a collaboration for orelabrutinib, an oral Bruton’s tyrosine kinase inhibitor aimed at treating multiple sclerosis. The agreement grants Biogen exclusive rights to orelabrutinib for multiple sclerosis and certain autoimmune diseases worldwide, while InnoCare retains rights in oncology within China. Biogen will pay InnoCare $125 million upfront, with potential milestones totaling $812.5 million and tiered royalties on future sales. The collaboration could significantly advance MS treatment options and reflects Biogen's ongoing commitment to neuroscience.
On July 8, 2021, Biogen, in collaboration with AbbVie and Pfizer, launched a new browser that links rare protein-coding genetic variants to human health. This resource is based on whole exome sequencing data from 300,000 UK Biobank participants, allowing global scientists to explore genetic associations with diseases. Managed by the Broad Institute, the platform aims to advance our understanding of genetic diseases and potentially guide therapeutic strategies. The UK Biobank project supports collaborative research in identifying links between genetics and health.
Biogen has received FDA approval for an updated label for ADUHELM (aducanumab-avwa), indicating that treatment should begin in patients with mild cognitive impairment or mild Alzheimer’s dementia. This clarification highlights the population studied in clinical trials and reinforces that there are no data supporting treatment initiation at different disease stages. The indication was granted under accelerated approval, contingent on future confirmatory trials. Alfred Sandrock emphasized the company’s commitment to aligning treatment practices with community needs.