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 Co., Ltd. and Biogen announced that the FDA accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb), an Alzheimer's treatment, seeking to convert its accelerated approval to traditional status. The application has received Priority Review, with a target action date of July 6, 2023. The sBLA is based on positive results from the Phase 3 Clarity AD trial, which met primary and secondary endpoints. This indicates the potential for LEQEMBI's continued approval contingent on confirming its clinical benefits in the ongoing study.
Eisai and Biogen announced that the Biologics License Application (BLA) for lecanemab (LEQEMBI) has received Priority Review from China’s National Medical Products Administration (NMPA). This designation aims to expedite the development and launch of significant new medicines. The submission includes data from the Phase II clinical trial and top-line results from the Phase III Clarity AD study, which focused on early Alzheimer’s disease. In the U.S., LEQEMBI received accelerated approval from the FDA on January 6, 2023, reflecting its potential in treating Alzheimer’s. Both companies will co-promote the drug globally.
Biogen (Nasdaq: BIIB) and Sage Therapeutics announced that the FDA has accepted the NDA filing for zuranolone as a treatment for major depressive disorder (MDD) and postpartum depression (PPD). This investigational drug aims to provide a rapid-acting, once-daily oral treatment over 14 days. The FDA granted priority review, with a PDUFA date set for August 5, 2023. Zuranolone's NDA incorporates data from multiple clinical programs including LANDSCAPE and NEST, involving several studies. The companies highlight the significant unmet need for effective and timely treatment of depression, which affects millions and carries substantial economic burdens.
Biogen (Nasdaq: BIIB) and Eisai announced that their application for lecanemab, an anti-amyloid-β antibody, received Priority Review from Japan's Ministry of Health, Labour and Welfare. This designation shortens the review period for medications that show high medical utility for serious diseases. The application was based on Phase III Clarity AD study results, indicating lecanemab's potential to reduce clinical decline in early Alzheimer’s disease (AD). Lecanemab has already gained accelerated approval from the FDA in the U.S. and submitted additional applications to regulatory bodies in Europe and China, indicating a robust global regulatory strategy.
Eisai and Biogen announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta antibody for early Alzheimer's disease. This follows the U.S. FDA's accelerated approval of lecanemab on January 6, 2023. Eisai is leading global development and regulatory submissions while co-commercializing with Biogen. A supplemental Biologics License Application for traditional approval has also been submitted to the FDA based on positive Phase III study results.
On January 15, 2023, Eisai Co., Ltd. and Biogen Inc. announced the submission of a marketing authorization application for lecanemab to treat mild cognitive impairment and early Alzheimer's disease in Japan. This follows positive Phase III clinical trial results showing significant reductions in clinical decline among patients. Lecanemab, known as LEQEMBI™ in the U.S., received accelerated FDA approval earlier in January 2023. However, common adverse effects include infusion reactions and amyloid-related imaging abnormalities. Eisai leads global development while both companies co-promote the drug.
Eisai Co., Ltd. and Biogen Inc. announced the submission of a marketing authorization application (MAA) for lecanemab (LEQEMBI™) to the European Medicines Agency (EMA) for treating early Alzheimer's disease. This application follows positive results from the Phase III Clarity AD study, which demonstrated a significant reduction in clinical decline in patients. The study met its primary endpoint, highlighting the potential of lecanemab in early AD. The companies aim to advance lecanemab's regulatory approval and commercialization globally.
On January 6, 2023, Eisai and Biogen announced the submission of a supplemental Biologics License Application (sBLA) for the traditional approval of LEQEMBI™ (lecanemab-irmb) to the FDA. This follows its previous accelerated approval based on Phase 2 data. The application is supported by the Phase 3 Clarity AD clinical trial, which met primary and secondary endpoints with significant results. Eisai plans to seek approval in Japan and the EU by March 31, 2023, enhancing access to Alzheimer’s treatment. This demonstrates commitment to patients amid ongoing challenges in Alzheimer's research.
The FDA has granted accelerated approval for LEQEMBI™ (lecanemab-irmb), a monoclonal antibody aimed at treating Alzheimer's disease. This decision was based on Phase 2 data indicating a reduction in amyloid-beta plaques in early-stage patients. LEQEMBI is intended for individuals with mild cognitive impairment or mild dementia, with treatment requiring baseline MRI scans and ongoing monitoring for potential side effects like amyloid-related imaging abnormalities (ARIA). Eisai plans a Supplemental Biologics License Application for traditional approval soon.
Biogen has announced the promotion of Priya Singhal, M.D., M.P.H. to Executive Vice President, Head of Development, following a restructuring that separates Research and Development into distinct functions. Dr. Singhal, who was previously Interim Head of R&D, will oversee development programs while a search for a new Executive Vice President, Head of Research, is underway. This strategic move, according to CEO Christopher Viehbacher, aims to enhance productivity and better manage risks and resources, ultimately aiming to deliver innovative therapies for challenging diseases.