Biogen Inc. - BIIB STOCK NEWS

Biogen announced the publication of results from the Phase 3 VALOR study for tofersen, targeting SOD1-ALS, in the New England Journal of Medicine. The 12-month data indicated that earlier initiation of tofersen significantly slowed functional decline in SOD1-ALS patients. Key findings included reduced SOD1 protein and neurofilament levels, suggesting a potential clinical benefit. The application for tofersen is under priority review by the FDA, with a decision expected by January 25, 2023.

Sage Therapeutics and Biogen present new analyses on zuranolone, an investigational treatment for major depressive disorder (MDD) and postpartum depression (PPD), at Psych Congress in New Orleans from September 17 to 20, 2022. Key findings from the SHORELINE Study show a median of 135 days for repeat treatment in the 30 mg cohort. Results indicate sustained improvements in MDD symptoms and a favorable safety profile. Zuranolone is being evaluated under Fast Track and Breakthrough Therapy Designations by the FDA.

Biogen (Nasdaq: BIIB) announced promising results from the Phase 2 LILAC study regarding litifilimab (BIIB059), an investigational drug for systemic lupus erythematosus (SLE). Results showed significant reductions in active joint counts compared to placebo, marking a potential breakthrough for SLE treatment. Biogen is progressing to Phase 3 studies, enrolling patients across 31 countries, and is set to begin a pivotal study for cutaneous lupus erythematosus (CLE). This reinforces Biogen's commitment to addressing lupus, a debilitating autoimmune disease affecting millions worldwide.

Eisai and Biogen presented new findings on lecanemab, an investigational treatment for early Alzheimer's disease, at the AAIC 2022. Key data included a Phase 1 study showing a 49.7% bioavailability for subcutaneous dosing compared to intravenous, with a half-life of approximately 7 days. A fixed subcutaneous dose of 720 mg was predicted to have similar efficacy and a lower incidence of amyloid-related imaging abnormalities (ARIA-E) compared to the IV dose. The FDA has accepted the Biologics License Application for lecanemab, with a PDUFA action date set for January 6, 2023.

Biogen announced positive results from the Phase 2 LILAC study for litifilimab (BIIB059), showing significant reduction in skin disease activity in cutaneous lupus erythematosus (CLE) compared to placebo. The study’s primary endpoint was met, indicating litifilimab's efficacy. Biogen is also conducting Phase 3 studies for systemic lupus erythematosus and plans a pivotal CLE study later this year. This advancement highlights the company's commitment to addressing unmet medical needs in lupus treatment.

Biogen announced the FDA's acceptance of its NDA for tofersen, a groundbreaking treatment for SOD1-ALS, a rare genetic form of amyotrophic lateral sclerosis affecting around 330 individuals in the U.S. If approved on January 25, 2023, it will be the first drug targeting a genetic cause of ALS. The NDA includes promising 12-month results showing that earlier treatment with tofersen significantly slowed clinical decline, with indications of reduced neurofilament levels. However, the VALOR study previously did not meet its primary endpoint. Serious side effects were noted in a minority of participants.

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.