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.
Following the FDA's accelerated approval of ADUHELM (aducanumab-avwa) for Alzheimer’s disease, Biogen and Eisai announced programs to support patients and families, particularly in underserved communities. Collaborations with Veterans Health Administration and CVS Health aim to address health disparities. A value-based agreement is in progress with Cigna, focusing on equitable access to treatment. ADUHELM, priced at $4,312 per infusion, is expected to significantly impact the economic burden of Alzheimer's, with annual care costs exceeding $600 billion in the U.S.
Biogen (Nasdaq: BIIB) and Eisai announced FDA's accelerated approval of ADUHELM (aducanumab-avwa) for Alzheimer’s treatment, the first to target amyloid beta plaques. Based on clinical trials, ADUHELM demonstrated a 59% to 71% reduction in plaques after 18 months. Approval is contingent on confirmatory trials verifying clinical benefits. The safety profile showed 41% of patients experienced Amyloid Related Imaging Abnormalities (ARIA). Biogen plans to conduct further trials to confirm the drug's efficacy.
Biogen announced positive results from its Phase 3 clinical trial of BAT1806, a biosimilar of ACTEMRA, indicating equivalent efficacy and safety in patients with moderate-to-severe rheumatoid arthritis. The study achieved its primary endpoint, demonstrating a comparable safety profile and pharmacokinetics to the reference drug. Global sales of ACTEMRA were reported at 2.8 billion CHF in 2020. Following these results, Biogen will pay Bio-Thera Solutions $30 million, with potential milestone payments pending. Biosimilars aim to provide cost savings and improve patient access to treatments.
Biogen and Ginkgo Bioworks have announced a collaboration to enhance AAV (adeno-associated virus) production for gene therapies. This partnership will leverage Ginkgo’s synthetic biology expertise to address current manufacturing challenges, potentially accelerating Biogen’s gene therapy pipeline. Ginkgo will receive an upfront payment of $5 million, along with the possibility of $115 million in milestone payments. The collaboration aims to optimize AAV production efficiency, which is crucial for treating neurological and neuromuscular diseases.
Biogen has announced that its new manufacturing facility in Solothurn, Switzerland, has received GMP multi-product licensure from SWISSMEDIC. This facility utilizes advanced cell culture technology for large-scale biopharmaceutical production. With over 500 employees, it is equipped to manufacture products like aducanumab and lecanemab. Additionally, the site aims for significant sustainability improvements, including an 83% reduction in carbon emissions and a goal to be fossil fuel-free by 2040, enhancing Biogen's ability to deliver high-quality therapies to patients.
Biogen announced topline results from the Phase 2/3 XIRIUS study for cotoretigene toliparvovec (BIIB112), a gene therapy for X-linked retinitis pigmentosa (XLRP). While the study did not meet its primary endpoint, positive trends were observed in secondary endpoints, particularly in visual acuity measures. The company plans to analyze complete data before determining next steps. Currently, there are no approved treatments for XLRP, a rare inherited retinal condition leading to vision loss and blindness.
Biogen has formed a collaboration with Envisagenics to utilize their AI-driven RNA splicing platform, SpliceCore®, to enhance research on Central Nervous System (CNS) diseases. This partnership aims to analyze RNA isoforms and their regulation, potentially leading to the identification of new drug targets. Envisagenics' platform offers access to a database of 7 million RNA splicing errors, significantly improving the efficiency of splicing error detection compared to traditional methods. This collaboration aligns with Biogen's goals in CNS drug discovery.
Biogen has exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, following promising results from a Phase 2a study. The study reported no incidences of symptomatic intracranial hemorrhage (sICH) and significant improvements in blood vessel reopening and patient recovery. Biogen will pay $18 million upfront, with potential additional payments of up to $335 million based on milestones. This acquisition aims to extend the treatment window for thrombolytic therapy beyond the current limitations, addressing a vital unmet medical need in stroke care.
Biogen (Nasdaq: BIIB) and Capsigen have launched a strategic research collaboration to develop novel adeno-associated virus (AAV) capsids aimed at advancing gene therapies for CNS and neuromuscular disorders. Utilizing Capsigen's TRADE™ platform, the partnership focuses on creating customized capsids for targeted disease profiles. Capsigen will receive a $15 million upfront payment, with potential milestones totaling up to $1.25 billion. This collaboration aims to enhance Biogen's gene therapy pipeline and accelerate the delivery of innovative treatments to patients.
Biogen has received a Complete Response Letter (CRL) from the FDA for its supplemental Biologic License Application for a subcutaneous delivery method of TYSABRI (natalizumab) to treat multiple sclerosis. The FDA's response indicates the filing cannot be approved as it stands. Biogen is reviewing the CRL and will decide on further actions. However, the intravenous administration of TYSABRI remains unaffected and continues to be a viable treatment for relapsing MS. The subcutaneous delivery was approved in March 2021 by the European Commission, and Biogen intends to pursue regulatory filings in other countries.