Biogen Inc Stock Price, News & Analysis

Biogen and Ginkgo Bioworks have announced a collaboration to enhance AAV (adeno-associated virus) production for gene therapies. This partnership will leverage Ginkgo’s synthetic biology expertise to address current manufacturing challenges, potentially accelerating Biogen’s gene therapy pipeline. Ginkgo will receive an upfront payment of $5 million, along with the possibility of $115 million in milestone payments. The collaboration aims to optimize AAV production efficiency, which is crucial for treating neurological and neuromuscular diseases.

Biogen has announced that its new manufacturing facility in Solothurn, Switzerland, has received GMP multi-product licensure from SWISSMEDIC. This facility utilizes advanced cell culture technology for large-scale biopharmaceutical production. With over 500 employees, it is equipped to manufacture products like aducanumab and lecanemab. Additionally, the site aims for significant sustainability improvements, including an 83% reduction in carbon emissions and a goal to be fossil fuel-free by 2040, enhancing Biogen's ability to deliver high-quality therapies to patients.

Biogen announced topline results from the Phase 2/3 XIRIUS study for cotoretigene toliparvovec (BIIB112), a gene therapy for X-linked retinitis pigmentosa (XLRP). While the study did not meet its primary endpoint, positive trends were observed in secondary endpoints, particularly in visual acuity measures. The company plans to analyze complete data before determining next steps. Currently, there are no approved treatments for XLRP, a rare inherited retinal condition leading to vision loss and blindness.

Biogen has formed a collaboration with Envisagenics to utilize their AI-driven RNA splicing platform, SpliceCore®, to enhance research on Central Nervous System (CNS) diseases. This partnership aims to analyze RNA isoforms and their regulation, potentially leading to the identification of new drug targets. Envisagenics' platform offers access to a database of 7 million RNA splicing errors, significantly improving the efficiency of splicing error detection compared to traditional methods. This collaboration aligns with Biogen's goals in CNS drug discovery.

Biogen has exercised its option to acquire TMS-007, an investigational drug for acute ischemic stroke, following promising results from a Phase 2a study. The study reported no incidences of symptomatic intracranial hemorrhage (sICH) and significant improvements in blood vessel reopening and patient recovery. Biogen will pay $18 million upfront, with potential additional payments of up to $335 million based on milestones. This acquisition aims to extend the treatment window for thrombolytic therapy beyond the current limitations, addressing a vital unmet medical need in stroke care.

Biogen (Nasdaq: BIIB) and Capsigen have launched a strategic research collaboration to develop novel adeno-associated virus (AAV) capsids aimed at advancing gene therapies for CNS and neuromuscular disorders. Utilizing Capsigen's TRADE™ platform, the partnership focuses on creating customized capsids for targeted disease profiles. Capsigen will receive a $15 million upfront payment, with potential milestones totaling up to $1.25 billion. This collaboration aims to enhance Biogen's gene therapy pipeline and accelerate the delivery of innovative treatments to patients.

Biogen has received a Complete Response Letter (CRL) from the FDA for its supplemental Biologic License Application for a subcutaneous delivery method of TYSABRI (natalizumab) to treat multiple sclerosis. The FDA's response indicates the filing cannot be approved as it stands. Biogen is reviewing the CRL and will decide on further actions. However, the intravenous administration of TYSABRI remains unaffected and continues to be a viable treatment for relapsing MS. The subcutaneous delivery was approved in March 2021 by the European Commission, and Biogen intends to pursue regulatory filings in other countries.

Biogen (Nasdaq: BIIB) released its 2020 Year in Review, highlighting its commitment to climate, health, and equity. The report reveals 11% reduction in absolute emissions and 10% in water withdrawal compared to 2019. Noteworthy goals include PVC-free packaging by 2025 and enhancing diversity in clinical trials. Additionally, the company has tied part of its employees' compensation to ESG metrics and disclosed pay equity analysis results indicating 99.7% alignment with equal pay principles. Biogen also invested over $90 million to support communities during the COVID-19 pandemic.

Eisai Co., Ltd. and Biogen Inc. announced the publication of a Phase 2b clinical trial for lecanemab (BAN2401), an investigational antibody for Alzheimer's disease, in the journal Alzheimer's Research and Therapy. The study reported a consistent reduction in clinical decline across multiple endpoints, supporting its potential for treating early Alzheimer's. The ongoing Phase 3 Clarity AD trial, which includes 1,795 symptomatic patients, aims to confirm these findings. The trials focus on reducing amyloid beta aggregates, which are believed to contribute to the disease's progression.