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.
The FDA Advisory Committee evaluated aducanumab for Alzheimer's treatment, resulting in a 1 yes, 8 no vote on its effectiveness based on Study 302. Study 103 received 0 yes votes supporting its efficacy. The committee expressed skepticism about aducanumab's primary evidence as effectiveness. Biogen CEO Michel Vounatsos acknowledged the unmet need for Alzheimer's treatment and emphasized ongoing FDA collaboration. The FDA aims to make a decision by March 7, 2021. Aducanumab, if approved, could be the first meaningful treatment altering Alzheimer's progression.
Biogen announced positive results from the Phase 2 LILAC study of BIIB059, a monoclonal antibody targeting BDCA2, for systemic lupus erythematosus (SLE). The study demonstrated a statistically significant reduction in total active joint count by 3.4 at 24 weeks (p=0.037) compared to placebo. The SLE Responder Index-4 (SRI-4) showed a higher response rate of 56.77% for BIIB059 versus 30.42% for placebo (p=0.003). Mild to moderate adverse events occurred in the majority, with serious events at 5.3% for BIIB059. Biogen aims to advance BIIB059 into Phase 3 trials, reinforcing its commitment to lupus treatment.
Biogen (Nasdaq: BIIB) and Eisai announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for aducanumab, an experimental Alzheimer’s disease treatment. If approved, aducanumab would be the first therapy to significantly alter the course of Alzheimer’s. Clinical trials demonstrated its ability to remove amyloid beta and improve clinical outcomes, indicating potential in slowing cognitive decline. Aducanumab is also under U.S. FDA review with a decision expected by March 7, 2021.
Abarca, a pharmacy benefit manager, announced a value-based agreement with Biogen (NASDAQ: BIIB) for drugs Avonex® and Tecfidera®, aimed at improving outcomes for Medicaid patients in Puerto Rico. This collaboration, initiated in 2017, represents the first publicly disclosed value-based agreement for Medicaid populations. Abarca's president emphasized that such contracts are vital for future pharmacy benefits, and Biogen's president expressed commitment to connecting real-world outcomes with therapy costs.
Samsung Bioepis and Biogen announced that the European Medicines Agency (EMA) has accepted their Marketing Authorisation Application for SB11, a proposed biosimilar of Lucentis (ranibizumab), targeting retinal vascular disorders. This application acceptance highlights their collaboration toward providing affordable treatment options. If approved, SB11 will enhance Biogen's biosimilar portfolio, supporting financial sustainability in healthcare. The collaboration aims to address pressing health needs and ensure patient access to essential therapies.
Biogen (Nasdaq: BIIB) has announced the launch of the Healthy Climate, Healthy Lives™ initiative, a $250 million, 20-year plan to eliminate fossil fuels from its operations by 2040. This initiative includes collaborations with leading institutions like MIT and Harvard to mitigate the health impacts of fossil fuels. Biogen aims to power operations with renewable energy, transition its fleet to electric vehicles, and support suppliers in reducing fossil fuel usage. This commitment positions Biogen as the first Fortune 500 company to strive for complete fossil fuel independence.
Biogen (NASDAQ: BIIB) announced new data highlighting the effectiveness and safety of its multiple sclerosis (MS) therapies at the MSVirtual2020 conference. Key findings from the Phase 3 study of VUMERITY® (diroximel fumarate) show improved gastrointestinal tolerability compared to TECFIDERA®. In two years, 90% of VUMERITY patients remained free from confirmed disability progression. Real-world studies indicate TYSABRI® (natalizumab) improved quality of life over Ocrevus®. Additionally, PLEGRIDY® and AVONEX® showed benefits in older patients with relapsing MS. Biogen is also advancing BIIB091, a BTK inhibitor for MS treatment.
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.