Biogen Inc Stock Price, News & Analysis

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.

Biogen (Nasdaq: BIIB) hosted a virtual Investor R&D Day to showcase its extensive neuroscience pipeline, featuring 33 clinical programs, with 12 in Phase 3. Key highlights include ADUHELM, the first Alzheimer’s therapy in 20 years, and lecanemab, a promising therapy in Phase 3 for early Alzheimer’s. Biogen is also advancing zuranolone for major depressive disorder, Tofersen for ALS, and therapies for stroke and lupus. The company emphasizes its innovative capabilities in neuroscience, aiming to transform treatment standards in high unmet need areas.

BYOOVIZ™ has made history as the first ophthalmology biosimilar approved by the FDA in the United States. This biosimilar, referencing LUCENTIS®, targets conditions like neovascular age-related macular degeneration and macular edema. Approximately 11 million individuals in the U.S. suffer from AMD, and BYOOVIZ™ aims to enhance patient access to affordable treatments. With over $100 billion in projected savings from biosimilars in the next five years, this approval marks a crucial advancement for retinal treatment options, reinforcing Biogen's commitment to improving healthcare accessibility.

Biogen (NASDAQ: BIIB) announced a positive opinion from the CHMP for VUMERITY, a next-generation oral fumarate for relapsing-remitting multiple sclerosis (RRMS). The Phase 3 EVOLVE-MS-2 study demonstrated low treatment discontinuation rates due to gastrointestinal tolerability, with VUMERITY at 1.6% compared to 6% for TECFIDERA. This new oral medication aims to support MS patients, especially during the COVID-19 pandemic. VUMERITY is already the top prescribed oral MS therapy in the U.S. and highlights Biogen's commitment to addressing treatment challenges in the MS community.

Biogen announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational drug for small fiber neuropathy (SFN). The 200 mg twice daily dose met its primary endpoint, showing significant reduction in average daily pain compared to placebo. However, the 350 mg dose did not meet its primary endpoint but indicated improvement in patient-reported outcomes. Both doses were generally well tolerated. Biogen plans to analyze CONVEY data further and continue developing vixotrigine for chronic neuropathic pain, addressing a significant unmet medical need.

Biogen has announced the initiation of the ASCEND Phase 3b clinical study to evaluate a higher dose of nusinersen in patients with later-onset spinal muscular atrophy (SMA) who have been previously treated with Evrysdi. The study aims to address unmet treatment needs and enhance patient outcomes. The protocol has been submitted to the U.S. FDA and plans to enroll up to 135 participants over approximately 2.5 years. Participants will receive two loading doses followed by maintenance doses while assessing efficacy through various clinical measures.

Biogen has announced results from the Phase 3b NOVA study, which evaluated the efficacy of a six-week dosing schedule of natalizumab (TYSABRI) for multiple sclerosis patients. The study, involving 499 participants, indicated a non-clinically meaningful difference in controlling disease activity compared to the approved four-week regimen. Although a reduction in the probability of progressive multifocal leukoencephalopathy (PML) was reported, safety profiles remained consistent. Further analysis is ongoing, with detailed results expected to be published in a scientific forum.

Eisai and Biogen presented preliminary results from the Phase 2b study of lecanemab (BAN2401), an investigational treatment for Alzheimer's disease, at the AAIC. After 18 months of treatment, lecanemab demonstrated a reduction in brain amyloid and slowed clinical decline in early Alzheimer's patients. The clinical effects remained significant even during an off-treatment gap. These findings suggest a potential disease-modifying effect of lecanemab. Ongoing research includes the Phase 3 Clarity AD study, with results expected by September 2022.

Biogen announced the launch of the ICARE AD-US study, a Phase 4 observational study evaluating the safety and effectiveness of ADUHELM in clinical practice. The study aims to enroll at least 16% of participants from Black/African American and Latinx communities, addressing underrepresentation in Alzheimer’s trials. With 6,000 participants expected over four years, the study will monitor long-term outcomes. Biogen stresses the importance of generating new data on ADUHELM while ensuring diverse patient representation to understand treatment impacts better.