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. develops and commercializes biopharmaceutical therapies focused on neurodegenerative diseases, rare diseases and adjacent specialty areas. Company news commonly covers Alzheimer’s disease therapy LEQEMBI with Eisai, spinal muscular atrophy treatment SPINRAZA, Friedreich’s ataxia therapy SKYCLARYS, postpartum depression therapy ZURZUVAE, ALS therapy QALSODY, multiple sclerosis products and CD20 collaboration revenue tied to Roche-partnered medicines.
Recurring updates include FDA review activity, supplemental biologics license applications, global regulatory status, clinical development programs, collaboration and licensing economics, asset-rights transactions and product demand trends. Biogen news also includes financial results, acquired in-process research and development expense, governance changes and corporate-status disclosures typical of a Nasdaq-listed biotechnology issuer.
Eisai and Biogen presented new findings on lecanemab, an investigational treatment for early Alzheimer's disease, at the AAIC 2022. Key data included a Phase 1 study showing a 49.7% bioavailability for subcutaneous dosing compared to intravenous, with a half-life of approximately 7 days. A fixed subcutaneous dose of 720 mg was predicted to have similar efficacy and a lower incidence of amyloid-related imaging abnormalities (ARIA-E) compared to the IV dose. The FDA has accepted the Biologics License Application for lecanemab, with a PDUFA action date set for January 6, 2023.
Biogen announced positive results from the Phase 2 LILAC study for litifilimab (BIIB059), showing significant reduction in skin disease activity in cutaneous lupus erythematosus (CLE) compared to placebo. The study’s primary endpoint was met, indicating litifilimab's efficacy. Biogen is also conducting Phase 3 studies for systemic lupus erythematosus and plans a pivotal CLE study later this year. This advancement highlights the company's commitment to addressing unmet medical needs in lupus treatment.
Biogen announced the FDA's acceptance of its NDA for tofersen, a groundbreaking treatment for SOD1-ALS, a rare genetic form of amyotrophic lateral sclerosis affecting around 330 individuals in the U.S. If approved on January 25, 2023, it will be the first drug targeting a genetic cause of ALS. The NDA includes promising 12-month results showing that earlier treatment with tofersen significantly slowed clinical decline, with indications of reduced neurofilament levels. However, the VALOR study previously did not meet its primary endpoint. Serious side effects were noted in a minority of participants.
Eisai and Biogen announced that the FDA accepted the Biologics License Application for lecanemab, aimed at treating early Alzheimer's disease. The application, submitted in May 2022, received Priority Review, with a PDUFA action date set for January 6, 2023. The ongoing Clarity AD Phase 3 clinical study has enrolled 1,795 patients, with primary endpoint results anticipated in Fall 2022. Lecanemab is a monoclonal antibody designed to target amyloid beta aggregates, representing a potential new treatment option for those affected by Alzheimer's.
Biogen (NASDAQ: BIIB) has announced a collaboration with Happify Health to enhance digital support for individuals living with Multiple Sclerosis (MS). Through this partnership, the AI-powered platform will provide MS patients with educational resources, treatment options, and community connections to improve their overall well-being. Happify Health’s approach combines digital therapeutics with expert consultations, tailored to the needs of MS patients. This collaboration signifies Biogen's commitment to advancing digital health in the MS treatment landscape.
Biogen Inc. (Nasdaq: BIIB) announced that the European Patent Office granted a patent for TECFIDERA (dimethyl fumarate), expiring in February 2028. This patent supports the approved dosing regimen of 480mg per day for treating multiple sclerosis, as recommended by the European Medicines Agency. TECFIDERA is the most prescribed oral medication for relapsing forms of MS globally, with over 560,000 patients treated, accumulating more than 1.1 million patient-years of exposure. Patent details are expected to be published in the European Patent Bulletin soon.
Biogen (Nasdaq: BIIB) is actively enrolling studies addressing unmet needs in spinal muscular atrophy (SMA). Recent findings from the RESPOND study indicate infants and toddlers face residual medical issues post-gene therapy Zolgensma. SPINRAZA treatment has shown good tolerability, with safety data from DEVOTE supporting the development of a higher dose of nusinersen. Biogen's commitment to SMA research includes continued investment in ongoing studies, aiming to enhance therapeutic options for patients and improve clinical outcomes.
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Biogen has entered a collaboration with Alectos Therapeutics to develop AL01811, a preclinical selective GBA2 inhibitor with potential as an oral treatment for Parkinson's Disease (PD). This agreement includes a $15 million upfront payment to Alectos and eligibility for up to $707.5 million in future milestone payments. Currently, no approved disease-modifying therapies exist for PD, affecting 10 million patients globally. Biogen aims to advance therapies for movement disorders that enhance patient quality of life.
Biogen and Bio-Thera Solutions announced promising Phase 3 results for BIIB800, a biosimilar to ACTEMRA. The trial involved 621 patients with moderate to severe rheumatoid arthritis, demonstrating comparable efficacy, safety, and immunogenicity between BIIB800 and the reference product. Key metrics showed ACR20 response rates of 68.97% for BIIB800 versus 64.82% for ACTEMRA at week 12, and 69.89% versus 67.94% at week 24. The data highlights Biogen's commitment to biosimilars, aiming to enhance patient access to essential treatments.