Biogen Inc Stock Price, News & Analysis

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.

Biogen (Nasdaq: BIIB) and Eisai announced FDA's accelerated approval of ADUHELM (aducanumab-avwa) for Alzheimer’s treatment, the first to target amyloid beta plaques. Based on clinical trials, ADUHELM demonstrated a 59% to 71% reduction in plaques after 18 months. Approval is contingent on confirmatory trials verifying clinical benefits. The safety profile showed 41% of patients experienced Amyloid Related Imaging Abnormalities (ARIA). Biogen plans to conduct further trials to confirm the drug's efficacy.

Biogen announced positive results from its Phase 3 clinical trial of BAT1806, a biosimilar of ACTEMRA, indicating equivalent efficacy and safety in patients with moderate-to-severe rheumatoid arthritis. The study achieved its primary endpoint, demonstrating a comparable safety profile and pharmacokinetics to the reference drug. Global sales of ACTEMRA were reported at 2.8 billion CHF in 2020. Following these results, Biogen will pay Bio-Thera Solutions $30 million, with potential milestone payments pending. Biosimilars aim to provide cost savings and improve patient access to treatments.

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.