Biogen Inc. - BIIB STOCK NEWS

Biogen and Eisai announced significant findings from ADUHELM's Phase 3 trials at the CTAD conference. Analysis of over 7,000 plasma samples revealed that ADUHELM notably lowered plasma p-tau181, a biomarker for tau tangles in Alzheimer's, in a dose- and time-dependent manner compared to placebo. The reduction in p-tau181 correlated with decreased amyloid beta plaque and less cognitive decline, supporting ADUHELM's efficacy. The EMERGE high-dose group showed a 13% decrease in p-tau181, while ENGAGE showed a 16% decrease. These results strengthen the case for ADUHELM as a treatment option in early Alzheimer's disease.

Eisai and Biogen have announced the use of plasma-based biomarkers in their Phase 3 AHEAD 3-45 clinical trial for lecanemab, an investigational treatment for Alzheimer's disease. This innovative approach aims to improve screening efficiency by identifying cognitively unimpaired individuals eligible for PET imaging. Results from 659 participants indicate that the Aβ42/40 ratio accurately predicts PET eligibility (AUC of 0.87). The trial, which began in July 2020, is pivotal for early Alzheimer's research and was presented at the CTAD conference.

Eisai Co., Ltd. and Biogen Inc. presented positive results from sensitivity analyses of lecanemab at the CTAD conference, demonstrating consistent efficacy for patients with early Alzheimer's disease (AD). Lecanemab outperformed placebo in several key assessments including the Alzheimer’s Disease Composite Score (ADCOMS). The Phase 2b trial achieved super-superiority in clinical change and identified an effective dosing strategy. The companies continue to advance lecanemab through ongoing studies, seeking regulatory approval under the FDA's accelerated pathway.

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.