Biogen Inc Stock Price, News & Analysis

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.

On July 8, 2021, Biogen, in collaboration with AbbVie and Pfizer, launched a new browser that links rare protein-coding genetic variants to human health. This resource is based on whole exome sequencing data from 300,000 UK Biobank participants, allowing global scientists to explore genetic associations with diseases. Managed by the Broad Institute, the platform aims to advance our understanding of genetic diseases and potentially guide therapeutic strategies. The UK Biobank project supports collaborative research in identifying links between genetics and health.

Biogen has received FDA approval for an updated label for ADUHELM (aducanumab-avwa), indicating that treatment should begin in patients with mild cognitive impairment or mild Alzheimer’s dementia. This clarification highlights the population studied in clinical trials and reinforces that there are no data supporting treatment initiation at different disease stages. The indication was granted under accelerated approval, contingent on future confirmatory trials. Alfred Sandrock emphasized the company’s commitment to aligning treatment practices with community needs.

Enel X is partnering with Biogen (Nasdaq: BIIB) to electrify its global fleet of over 1,000 vehicles by 2025. This initiative supports Biogen's commitment to a fossil fuel-free future by 2040 and aims to reduce emissions by at least 7,000 pounds of CO2 per electric vehicle annually. Enel X will provide JuiceBox charging stations and IoT software to optimize fleet management and reduce operating costs. The collaboration enhances Biogen's Healthy Climate, Healthy Lives initiative, contributing to climate change and public health goals.

Samsung Bioepis and Biogen (Nasdaq: BIIB) announced that the European Medicines Agency’s CHMP has issued a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®. BYOOVIZ is recommended for treating serious retinal disorders, including wet age-related macular degeneration and diabetic retinopathy. This opinion will be forwarded to the European Commission for final marketing authorization. If approved, BYOOVIZ will expand Biogen's biosimilars portfolio, enhancing patient access to vital treatments for retinal vascular diseases.