Biogen Inc. - BIIB STOCK NEWS

Eisai and Biogen announced that the FDA has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational antibody aimed at treating Alzheimer's disease. This designation facilitates faster drug development for serious conditions. The decision is based on positive Phase 2b trial outcomes involving 856 patients, demonstrating a reduction in clinical decline associated with Alzheimer's. The companies are also conducting additional studies, including the Clarity AD and AHEAD 3-45 trials. The prospects depend on ongoing clinical successes and regulatory reviews.

Biogen has initiated the global Phase 3 TOPAZ-1 study to assess the efficacy and safety of BIIB059, a monoclonal antibody targeting blood dendritic cell antigen 2, in patients with active systemic lupus erythematosus (SLE). Following positive results from the Phase 2 LILAC study, which demonstrated significant disease activity reduction, the TOPAZ-1 trial will enroll 540 adults at around 135 locations worldwide. This study aims to provide a new therapeutic option for SLE, especially affecting diverse populations.

Biogen (Nasdaq: BIIB) announced that its Phase 2 TANGO study of gosuranemab, an investigational anti-tau antibody aimed at treating Alzheimer’s disease, did not achieve its primary efficacy endpoint. The study, involving 654 participants over 78 weeks, showed no significant treatment benefit compared to placebo on key cognitive scales. Although gosuranemab was well-tolerated, the study has been terminated, and clinical development of the drug will discontinue. Biogen will continue to analyze data and will present results at a medical congress.

The WATERFALL Study conducted by Sage Therapeutics and Biogen reported positive results for zuranolone (50 mg) in treating major depressive disorder (MDD). At Day 15, patients showed a significant reduction in depressive symptoms (HAMD-17 score, p=0.0141) compared to placebo. The drug demonstrated a rapid onset of effect and a high completion rate of 90.3%. Zuranolone was generally well-tolerated, with treatment emergent adverse events (TEAEs) at 60.1%. The study highlights zuranolone's potential as a new class of rapid-acting antidepressant, promising a breakthrough in MDD treatment.

Sage Therapeutics and Biogen announced that the Phase 3 WATERFALL Study for zuranolone (SAGE-217/BIIB125) in Major Depressive Disorder (MDD) met its primary endpoint. Zuranolone 50 mg showed a significant improvement in depressive symptoms compared to placebo, with a mean change from baseline in HAMD-17 total score at Day 15 of -14.1 versus -12.3 for placebo (p=0.0141). Zuranolone demonstrated a favorable safety profile, with common adverse events being mild to moderate. The U.S. FDA has granted Breakthrough Therapy Designation for zuranolone, indicating its potential as a new treatment option.

Biogen announced the Phase 3 STAR study results for timrepigene emparvovec (BIIB111/AAV2-REP1), aimed at treating choroideremia, a rare retinal disease. Unfortunately, the study did not achieve its primary endpoint of a ≥15 letter improvement in best corrected visual acuity at Month 12 compared to a control group. Additionally, key secondary endpoints were also unmet. Despite the disappointing results, Biogen emphasized the importance of the insights gained for future therapeutic innovations. The company will analyze the full data set to determine the next steps for the clinical development program.

Biogen (Nasdaq: BIIB) will host an Investor Day on September 21, 2021, focusing on its extensive pipeline in neuroscience and related areas. The event, aimed at investors, will be available via a live webcast at 10:00 a.m. ET and will later be archived. Biogen is recognized for its leadership in treating neurological diseases and holds a diverse portfolio, including multiple sclerosis therapies and groundbreaking treatments for spinal muscular atrophy. More details will follow on their investors' webpage.

Biogen (Nasdaq: BIIB) announced new data highlighting the long-term benefits of SPINRAZA in treating spinal muscular atrophy (SMA) at the Cure SMA 2021 meeting. An analysis showed that 92% of infants treated pre-symptomatically maintained swallowing ability after 3.8 years. Furthermore, an investigational higher dose of SPINRAZA may yield significant improvements in motor function. The ongoing DEVOTE study explores this higher dosing regimen, with initial safety data supporting its development. These findings reinforce SPINRAZA’s efficacy across different age groups and SMA types.

Following the FDA's accelerated approval of ADUHELM (aducanumab-avwa) for Alzheimer’s disease, Biogen and Eisai announced programs to support patients and families, particularly in underserved communities. Collaborations with Veterans Health Administration and CVS Health aim to address health disparities. A value-based agreement is in progress with Cigna, focusing on equitable access to treatment. ADUHELM, priced at $4,312 per infusion, is expected to significantly impact the economic burden of Alzheimer's, with annual care costs exceeding $600 billion in the U.S.