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.
Biogen (Nasdaq: BIIB) presented new data on multiple sclerosis (MS) disease measurement at the ECTRIMS meeting from October 26-28, 2022. Key highlights include the effectiveness of the Manual Dexterity Test (MDT) and Konectom™ smartphone technology in monitoring MS progression. The research utilized machine learning and AI to analyze MRI scans, revealing specific lesion patterns. Additionally, real-world data from the MS PATHS network informs precision medicine models for predicting individual treatment responses, enhancing personalized care and patient outcomes.
Biogen presented new data from its multiple sclerosis (MS) portfolio at the ECTRIMS Congress, showcasing the final results from the Phase 3 EVOLVE-MS-1 trial for VUMERITY (diroximel fumarate). The study indicated an 81.6% reduction in annualized relapse rates among 1,057 patients, with favorable tolerability. Additionally, patient-reported outcomes showed TYSABRI (natalizumab) outperformed Ocrevus (ocrelizumab) in various clinical measures. Data on PLEGRIDY and AVONEX revealed no adverse effects on child development from interferon exposure during pregnancy.
Biogen announced on October 17, 2022, that the FDA has extended the review period for the new drug application (NDA) for tofersen, an investigational treatment for SOD1 amyotrophic lateral sclerosis (ALS), by three months. The new PDUFA date is set for April 25, 2023. The extension results from a Major Amendment in response to FDA information requests. Tofersen aims to target SOD1 mRNA to reduce harmful protein synthesis. Biogen maintains an early access program for tofersen as they continue their commitment to ALS research amid the ongoing clinical evaluations.
Zuranolone 50 mg has shown improvement in depressive symptoms by Day 15 in the SKYLARK Study, with statistically significant results also at Days 3, 28, and 45. The study, presented at the ECNP Congress, highlighted the drug's rapid effect in women suffering from postpartum depression (PPD). Zuranolone was well-tolerated, with mild to moderate treatment-emergent adverse events. A New Drug Application (NDA) submission to the FDA for zuranolone is underway, aiming for completion in late 2022.
GoodRx (NASDAQ: GDRX) has launched a new feature called Provider Mode, designed to streamline the enrollment process for healthcare providers (HCPs) prescribing VUMERITY® (diroximel fumarate) for relapsing multiple sclerosis. This digital form helps reduce paperwork and errors, significantly speeding up patient treatment initiation. Since its rollout, Provider Mode has achieved a 90% opt-in rate from providers, with Biogen (NASDAQ: BIIB) being the first pharmaceutical partner to use this system. This collaboration aims to enhance patient care by simplifying the therapy start process.
Biogen (Nasdaq: BIIB) announced the acceptance of its Marketing Authorization Application (MAA) for BIIB800, a biosimilar candidate of RoACTEMRA®, by the European Medicines Agency (EMA). This follows positive Phase 3 trial data demonstrating BIIB800's equivalent efficacy and safety compared to the reference product for rheumatoid arthritis treatment. The filing is a step towards enhancing patient access to affordable biosimilar therapies in Europe. Biogen has exclusive rights for BIIB800's commercialization in multiple regions, with an emphasis on sustainable healthcare solutions.
Eisai and Biogen announced positive topline results from the Phase 3 Clarity AD trial for lecanemab, an investigational treatment for early Alzheimer's disease. The study showed a 27% reduction in clinical decline over 18 months compared to placebo, with highly statistically significant results across all key endpoints. Despite an incidence of 21.3% for amyloid-related imaging abnormalities (ARIA), this was within expectations. Eisai plans to file for regulatory approval in the U.S., Japan, and Europe by the end of FY2022, aiming for early access to this potential Alzheimer’s therapy.
Biogen announced the publication of results from the Phase 3 VALOR study for tofersen, targeting SOD1-ALS, in the New England Journal of Medicine. The 12-month data indicated that earlier initiation of tofersen significantly slowed functional decline in SOD1-ALS patients. Key findings included reduced SOD1 protein and neurofilament levels, suggesting a potential clinical benefit. The application for tofersen is under priority review by the FDA, with a decision expected by January 25, 2023.
Sage Therapeutics and Biogen present new analyses on zuranolone, an investigational treatment for major depressive disorder (MDD) and postpartum depression (PPD), at Psych Congress in New Orleans from September 17 to 20, 2022. Key findings from the SHORELINE Study show a median of 135 days for repeat treatment in the 30 mg cohort. Results indicate sustained improvements in MDD symptoms and a favorable safety profile. Zuranolone is being evaluated under Fast Track and Breakthrough Therapy Designations by the FDA.
Biogen (Nasdaq: BIIB) announced promising results from the Phase 2 LILAC study regarding litifilimab (BIIB059), an investigational drug for systemic lupus erythematosus (SLE). Results showed significant reductions in active joint counts compared to placebo, marking a potential breakthrough for SLE treatment. Biogen is progressing to Phase 3 studies, enrolling patients across 31 countries, and is set to begin a pivotal study for cutaneous lupus erythematosus (CLE). This reinforces Biogen's commitment to addressing lupus, a debilitating autoimmune disease affecting millions worldwide.