Biogen Inc. - BIIB STOCK NEWS

Eisai and Biogen presented new findings on lecanemab, an investigational treatment for early Alzheimer's disease, at the CTAD conference on November 9-12, 2021. The results from the Phase 2b study and the open-label extension indicated significant reductions in brain amyloid levels within three months, with over 80% of participants achieving amyloid negative status by 12-18 months. The study suggests a potential disease-modifying effect of lecanemab, maintaining clinical benefits even after temporary treatment discontinuation. Additionally, lecanemab exhibited a favorable safety profile, with low incidence of ARIA-E.

Biogen (BIIB) announced it will present new data on ADUHELM at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference from November 9-12, 2021. Highlighting the largest dataset in early Alzheimer’s research with over 3,000 patients, a late-breaking presentation will focus on ADUHELM's effect on plasma phosphorylated tau181 reduction, correlating with amyloid beta plaques and clinical decline. Additionally, data from the EMBARK trial will be discussed, examining the impact of stopping treatment on disease progression. The findings aim to advance understanding and treatment decisions in Alzheimer's disease.

Sage Therapeutics and Biogen announced plans to submit a New Drug Application (NDA) for the investigational drug zuranolone aimed at treating Major Depressive Disorder (MDD) in the second half of 2022. Following successful discussions with the FDA, their filing will include data from key clinical studies. A subsequent NDA for Postpartum Depression (PPD) is anticipated in early 2023. Both companies aim to launch marketing for zuranolone upon FDA approval, presenting a potential solution for millions suffering from depression worldwide.

Biogen (Nasdaq: BIIB) announced topline results from its Phase 3 VALOR study evaluating tofersen, an investigational drug for SOD1 amyotrophic lateral sclerosis (ALS). The study failed to meet its primary endpoint on the ALSFRS-R scale; however, signs of reduced disease progression were observed in secondary endpoints. Early initiation of tofersen was associated with improved clinical outcomes. In response to high unmet medical needs, Biogen plans to expand its early access program to offer tofersen to more SOD1-ALS patients. Results were presented at the ANA Annual Meeting on October 17, 2021.

Biogen Inc. (NASDAQ: BIIB) announced the upcoming presentation of topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067) at the American Neurological Association (ANA) virtual meeting from October 17-19, 2021. The study focuses on the efficacy and safety of tofersen in patients with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). Tofersen aims to reduce SOD1 protein production by degrading SOD1 mRNA. The study's findings, presented by Dr. Timothy Miller, could significantly impact treatment strategies for SOD1-ALS.

Biogen announced key findings from its multiple sclerosis therapies at the ECTRIMS virtual meeting on October 13-15, 2021. The Phase 3b NOVA study showed that every six-week dosing of TYSABRI (natalizumab) maintains efficacy similar to the four-week regimen, with 96.9% relapse-free patients at 72 weeks. A real-world analysis revealed lower relapse risk with TYSABRI compared to Ocrevus (ocrelizumab). Additionally, new data from the EVOLVE-MS-2 study confirmed favorable gastrointestinal tolerability for VUMERITY (diroximel fumarate) during dose titration, potentially enhancing treatment compliance.

Biogen (Nasdaq: BIIB) released findings from the MS PATHS study indicating that 100% of multiple sclerosis (MS) patients treated with natalizumab, interferons, or fumarates generated an antibody response after COVID-19 vaccination. However, only about 40% of those using anti-CD20 and S1P therapies showed similar responses. This analysis, based on data from 322 participants, highlights the varying impacts of MS disease-modifying therapies (DMTs) on vaccine efficacy. Biogen is presenting additional findings at the ECTRIMS virtual meeting from October 13-15, 2021.

Sage Therapeutics and Biogen announced promising data from their clinical programs for zuranolone, targeting major depressive disorder (MDD) and postpartum depression (PPD). Results from the Phase 3 WATERFALL Study showed significant reductions in depressive symptoms, with improvements observed as early as Day 3. Safety profiles were favorable, showing no common side effects linked to current antidepressants. A conference call is scheduled for October 4, 2021, to discuss findings presented at the ECNP Congress.

Eisai Co., Ltd. and Biogen have initiated a rolling submission of a Biologics License Application (BLA) for lecanemab (BAN2401) to the U.S. FDA, targeting early Alzheimer's disease. This application leverages data from a Phase 2b trial showing significant amyloid plaque reduction and decreased clinical decline. The submission is under the accelerated approval pathway, following a Breakthrough Therapy designation for lecanemab. The ongoing Phase 3 Clarity AD trial will serve as a confirmatory study once results are available.