Biogen Inc. - BIIB STOCK NEWS

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.

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.