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 has partnered with Alcyone Therapeutics to develop the ThecaFlex DRx™ System, an implantable device aimed at delivering antisense oligonucleotide therapies for neurological disorders like SMA and ALS. This collaboration includes a $10 million upfront payment and potential milestone payments up to $41 million, contingent on development achievements. The ThecaFlex DRx™ has received CE Mark in Europe and Breakthrough Device Designation from the FDA, paving the way for future clinical studies. Biogen seeks to enhance patient treatment experiences with this innovative delivery method.
Eisai Co., Ltd. and Biogen Inc. have initiated the submission of a Biologics License Application (BLA) for lecanemab to China's National Medical Products Administration (NMPA). This Category 1 drug aims to treat Alzheimer's disease and has shown positive results in clinical trials, including the Phase III Clarity AD study, which met its primary and key secondary endpoints. The submission package includes data from Phase II and III trials with significant efficacy outcomes. Eisai plans to seek additional approvals in Japan and Europe by March 31, 2023.
Biogen (Nasdaq: BIIB) has announced a commercialization agreement with Genentech regarding glofitamab, a bispecific antibody targeting B-cell non-Hodgkin’s lymphoma. Biogen will incur no payment obligations and is set to earn tiered royalties on net sales in the U.S. Glofitamab, currently in development, is designed to activate T-cells to eliminate cancer B cells. Pending regulatory approval, it may become a first-in-class treatment. This collaboration reinforces Biogen's long-standing partnership with Genentech in developing anti-CD20 antibodies.
Biogen Inc. (Nasdaq: BIIB) announced the FDA's acceptance for review of its abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar referencing ACTEMRA® (tocilizumab). This biosimilar is aimed at treating moderate to severe rheumatoid arthritis and is supported by Phase 3 clinical trial data showing equivalent efficacy and safety compared to the reference product. The data was previously presented at the European Congress of Rheumatology and ACR. Biogen holds exclusive rights to BIIB800, excluding China, under an agreement with Bio-Thera Solutions.
Sage Therapeutics and Biogen have completed the NDA submission for zuranolone, a rapid-acting oral treatment for major depressive disorder (MDD) and postpartum depression (PPD). This 14-day treatment aims to provide quicker symptom relief compared to existing therapies. The NDA integrates data from the LANDSCAPE and NEST programs, which included multiple studies in adults with MDD and women with PPD. Zuranolone has received Fast Track and Breakthrough Therapy designations by the FDA, indicating its potential significance in treating depression.
Biogen (Nasdaq: BIIB) announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for tofersen, aimed at treating SOD1-ALS, a rare form of amyotrophic lateral sclerosis affecting approximately 2% of ALS patients. Tofersen is positioned to be the first therapy targeting a genetic cause of ALS. The MAA includes comprehensive results from various clinical trials, including the Phase 3 VALOR study. Tofersen is also under FDA review, with a Prescription Drug User Fee Act action date set for April 25, 2023, as Biogen continues its commitment to ALS research.
Eisai and Biogen announced the presentation of results from the global Phase 3 Clarity AD clinical study of lecanemab, an investigational antibody for early Alzheimer's disease, at the CTAD conference. The study involved 1,795 participants and demonstrated significant clinical benefits, including a 27% reduction in cognitive decline compared to placebo over 18 months. Key secondary endpoints, such as amyloid plaque reduction, also showed highly statistically significant results. While ARIA-related side effects were noted, they were largely mild to moderate, with no deaths attributed to lecanemab during the study.
Eisai and Biogen announced the publication of results from the Phase 3 Clarity AD study of lecanemab, an investigational antibody aimed at treating early Alzheimer's disease with confirmed amyloid pathology. The results, published in the New England Journal of Medicine, reinforce Eisai's commitment to transparency in disclosing data on lecanemab. Eisai leads global development and regulatory submissions, targeting expedited delivery of lecanemab to patients. The FDA's decision on traditional approval is anticipated around January 6, 2023.
Sage Therapeutics and Biogen will host a joint investor webcast on December 6 at 8:00 a.m. ET to discuss commercialization strategies for zuranolone, their investigational treatment for major depressive disorder and postpartum depression. The webcast will address the clinical data of zuranolone and the unmet need in these conditions. Investors can access the live webcast on both companies' investor webpages and it will be available for up to 30 days post-event.
Biogen Inc. (NASDAQ: BIIB) announced the appointment of Christopher A. Viehbacher as President and CEO, effective November 14, 2022. Viehbacher, who succeeds Michel Vounatsos, brings extensive experience from roles at GlaxoSmithKline and Sanofi, where he notably enhanced R&D pipelines and shareholder value. The transition aims to leverage Biogen's innovative portfolio in neurological diseases and address significant healthcare challenges. Vounatsos will assist in the transition, leaving a robust foundation for growth, with a focus on patients and stakeholders.