Biogen Inc. - BIIB STOCK NEWS

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 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.

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.

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.

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.