Biogen Inc Stock Price, News & Analysis

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.

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.