Biogen Inc Stock Price, News & Analysis

Eisai and Biogen announced that the FDA accepted the Biologics License Application for lecanemab, aimed at treating early Alzheimer's disease. The application, submitted in May 2022, received Priority Review, with a PDUFA action date set for January 6, 2023. The ongoing Clarity AD Phase 3 clinical study has enrolled 1,795 patients, with primary endpoint results anticipated in Fall 2022. Lecanemab is a monoclonal antibody designed to target amyloid beta aggregates, representing a potential new treatment option for those affected by Alzheimer's.

Biogen (NASDAQ: BIIB) has announced a collaboration with Happify Health to enhance digital support for individuals living with Multiple Sclerosis (MS). Through this partnership, the AI-powered platform will provide MS patients with educational resources, treatment options, and community connections to improve their overall well-being. Happify Health’s approach combines digital therapeutics with expert consultations, tailored to the needs of MS patients. This collaboration signifies Biogen's commitment to advancing digital health in the MS treatment landscape.

Biogen Inc. (Nasdaq: BIIB) announced that the European Patent Office granted a patent for TECFIDERA (dimethyl fumarate), expiring in February 2028. This patent supports the approved dosing regimen of 480mg per day for treating multiple sclerosis, as recommended by the European Medicines Agency. TECFIDERA is the most prescribed oral medication for relapsing forms of MS globally, with over 560,000 patients treated, accumulating more than 1.1 million patient-years of exposure. Patent details are expected to be published in the European Patent Bulletin soon.

Biogen (Nasdaq: BIIB) is actively enrolling studies addressing unmet needs in spinal muscular atrophy (SMA). Recent findings from the RESPOND study indicate infants and toddlers face residual medical issues post-gene therapy Zolgensma. SPINRAZA treatment has shown good tolerability, with safety data from DEVOTE supporting the development of a higher dose of nusinersen. Biogen's commitment to SMA research includes continued investment in ongoing studies, aiming to enhance therapeutic options for patients and improve clinical outcomes.

Biogen has entered a collaboration with Alectos Therapeutics to develop AL01811, a preclinical selective GBA2 inhibitor with potential as an oral treatment for Parkinson's Disease (PD). This agreement includes a $15 million upfront payment to Alectos and eligibility for up to $707.5 million in future milestone payments. Currently, no approved disease-modifying therapies exist for PD, affecting 10 million patients globally. Biogen aims to advance therapies for movement disorders that enhance patient quality of life.

Biogen and Bio-Thera Solutions announced promising Phase 3 results for BIIB800, a biosimilar to ACTEMRA. The trial involved 621 patients with moderate to severe rheumatoid arthritis, demonstrating comparable efficacy, safety, and immunogenicity between BIIB800 and the reference product. Key metrics showed ACR20 response rates of 68.97% for BIIB800 versus 64.82% for ACTEMRA at week 12, and 69.89% versus 67.94% at week 24. The data highlights Biogen's commitment to biosimilars, aiming to enhance patient access to essential treatments.

Biogen announced new 12-month data for tofersen, an investigational drug for SOD1-ALS, showing earlier initiation slowed declines in clinical, respiratory, and muscle functions, along with improving quality of life. The analysis, based on the Phase 3 VALOR study, indicated that early initiation may lower the risk of death or permanent ventilation, with robust reductions in neurofilament levels, marking significant neurodegenerative impacts. Despite not meeting primary endpoints in earlier trials, the data suggest potential meaningful benefits for SOD1-ALS patients.

Sage Therapeutics and Biogen announced successful results from the Phase 3 SKYLARK Study of zuranolone, an oral treatment for postpartum depression (PPD). The study achieved its primary endpoint, showing a statistically significant improvement in depressive symptoms at Day 15 with a change from baseline HAMD-17 total score of -15.6 for zuranolone compared to -11.6 for placebo (p=0.0007). Additionally, safety profiles were consistent with previous studies. Zuranolone aims to provide rapid relief for the one in eight women affected by PPD in the U.S.