Biogen Inc Stock Price, News & Analysis

On July 8, 2021, Biogen, in collaboration with AbbVie and Pfizer, launched a new browser that links rare protein-coding genetic variants to human health. This resource is based on whole exome sequencing data from 300,000 UK Biobank participants, allowing global scientists to explore genetic associations with diseases. Managed by the Broad Institute, the platform aims to advance our understanding of genetic diseases and potentially guide therapeutic strategies. The UK Biobank project supports collaborative research in identifying links between genetics and health.

Biogen has received FDA approval for an updated label for ADUHELM (aducanumab-avwa), indicating that treatment should begin in patients with mild cognitive impairment or mild Alzheimer’s dementia. This clarification highlights the population studied in clinical trials and reinforces that there are no data supporting treatment initiation at different disease stages. The indication was granted under accelerated approval, contingent on future confirmatory trials. Alfred Sandrock emphasized the company’s commitment to aligning treatment practices with community needs.

Enel X is partnering with Biogen (Nasdaq: BIIB) to electrify its global fleet of over 1,000 vehicles by 2025. This initiative supports Biogen's commitment to a fossil fuel-free future by 2040 and aims to reduce emissions by at least 7,000 pounds of CO2 per electric vehicle annually. Enel X will provide JuiceBox charging stations and IoT software to optimize fleet management and reduce operating costs. The collaboration enhances Biogen's Healthy Climate, Healthy Lives initiative, contributing to climate change and public health goals.

Samsung Bioepis and Biogen (Nasdaq: BIIB) announced that the European Medicines Agency’s CHMP has issued a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®. BYOOVIZ is recommended for treating serious retinal disorders, including wet age-related macular degeneration and diabetic retinopathy. This opinion will be forwarded to the European Commission for final marketing authorization. If approved, BYOOVIZ will expand Biogen's biosimilars portfolio, enhancing patient access to vital treatments for retinal vascular diseases.

Eisai and Biogen announced that the FDA has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational antibody aimed at treating Alzheimer's disease. This designation facilitates faster drug development for serious conditions. The decision is based on positive Phase 2b trial outcomes involving 856 patients, demonstrating a reduction in clinical decline associated with Alzheimer's. The companies are also conducting additional studies, including the Clarity AD and AHEAD 3-45 trials. The prospects depend on ongoing clinical successes and regulatory reviews.

Biogen has initiated the global Phase 3 TOPAZ-1 study to assess the efficacy and safety of BIIB059, a monoclonal antibody targeting blood dendritic cell antigen 2, in patients with active systemic lupus erythematosus (SLE). Following positive results from the Phase 2 LILAC study, which demonstrated significant disease activity reduction, the TOPAZ-1 trial will enroll 540 adults at around 135 locations worldwide. This study aims to provide a new therapeutic option for SLE, especially affecting diverse populations.

Biogen (Nasdaq: BIIB) announced that its Phase 2 TANGO study of gosuranemab, an investigational anti-tau antibody aimed at treating Alzheimer’s disease, did not achieve its primary efficacy endpoint. The study, involving 654 participants over 78 weeks, showed no significant treatment benefit compared to placebo on key cognitive scales. Although gosuranemab was well-tolerated, the study has been terminated, and clinical development of the drug will discontinue. Biogen will continue to analyze data and will present results at a medical congress.

The WATERFALL Study conducted by Sage Therapeutics and Biogen reported positive results for zuranolone (50 mg) in treating major depressive disorder (MDD). At Day 15, patients showed a significant reduction in depressive symptoms (HAMD-17 score, p=0.0141) compared to placebo. The drug demonstrated a rapid onset of effect and a high completion rate of 90.3%. Zuranolone was generally well-tolerated, with treatment emergent adverse events (TEAEs) at 60.1%. The study highlights zuranolone's potential as a new class of rapid-acting antidepressant, promising a breakthrough in MDD treatment.

Sage Therapeutics and Biogen announced that the Phase 3 WATERFALL Study for zuranolone (SAGE-217/BIIB125) in Major Depressive Disorder (MDD) met its primary endpoint. Zuranolone 50 mg showed a significant improvement in depressive symptoms compared to placebo, with a mean change from baseline in HAMD-17 total score at Day 15 of -14.1 versus -12.3 for placebo (p=0.0141). Zuranolone demonstrated a favorable safety profile, with common adverse events being mild to moderate. The U.S. FDA has granted Breakthrough Therapy Designation for zuranolone, indicating its potential as a new treatment option.