Biogen Inc Stock Price, News & Analysis

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.

Biogen and Ionis Pharmaceuticals reported positive topline data from a Phase 1b clinical trial of BIIB080, aimed at treating mild Alzheimer's disease. The trial demonstrated significant dose-dependent reductions in tau protein levels in cerebrospinal fluid, achieving mean reductions of 30% to 49% across various dosing schedules. All participants completed the treatment phases, with no serious adverse events reported. These findings underscore the potential of BIIB080 and Ionis' antisense technology in addressing neurodegenerative diseases, paving the way for further clinical investigations.

Biogen (Nasdaq: BIIB) presented new data on ADUHELM™ at the Alzheimer’s Association International Conference. Key findings from the EMERGE trial indicate that high-dose aducanumab treatment significantly slows cognitive, functional, and behavioral decline in early Alzheimer’s disease. Data included correlations between amyloid beta reductions and clinical decline, supporting the drug's efficacy. ADUHELM's accelerated FDA approval necessitates verification of clinical benefits in ongoing studies. The company aims to engage with the dementia research community through these findings.

Biogen (Nasdaq: BIIB) announced its participation at the Alzheimer’s Association International Conference (AAIC) from July 26-30, 2021, featuring multiple presentations on its Alzheimer's disease portfolio, including ADUHELM (aducanumab-avwa). This drug, recently granted FDA accelerated approval, is aimed at treating mild cognitive impairment and mild dementia, showing promise in reducing amyloid beta plaques. Biogen will present new analyses from several studies and lead a late-breaking presentation on the real-world observational Phase 4 study, ICARE AD-US, to assess ADUHELM's long-term effectiveness.

Biogen's ADUHELM, the first Alzheimer’s treatment approved since 2003, targets amyloid plaques in the brain. Approved by the FDA on June 7, 2021, the drug's effectiveness is based on clinical trials involving over 3,000 patients and substantial documentation. Despite criticisms regarding its approval process, Biogen emphasizes the importance of providing treatment options to patients. ADUHELM's approval has renewed investment in Alzheimer’s research, with the company committed to ensuring transparency and collaboration with regulatory agencies.

Mirimus announced a collaboration with Biogen (NASDAQ: BIIB) aimed at developing RNAi therapeutics for various neurological diseases. The specifics of this strategic partnership are undisclosed, but Mirimus will leverage its expertise in RNAi and CRISPR technologies to create potential therapeutics. If the feasibility of these treatments is confirmed, further pre-clinical development could follow. This collaboration expands Mirimus's role in therapeutic development, building on its previous successes in creating animal models and advancing COVID-19 testing methods.

Biogen and InnoCare Pharma have announced a collaboration for orelabrutinib, an oral Bruton’s tyrosine kinase inhibitor aimed at treating multiple sclerosis. The agreement grants Biogen exclusive rights to orelabrutinib for multiple sclerosis and certain autoimmune diseases worldwide, while InnoCare retains rights in oncology within China. Biogen will pay InnoCare $125 million upfront, with potential milestones totaling $812.5 million and tiered royalties on future sales. The collaboration could significantly advance MS treatment options and reflects Biogen's ongoing commitment to neuroscience.