Biogen Inc. - BIIB STOCK NEWS

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.

Biogen (Nasdaq: BIIB) announced significant data from the SPINRAZA clinical development program at the American Academy of Neurology 2021 Virtual Annual Meeting. The DEVOTE study indicates no new safety concerns when using a higher dose of SPINRAZA (nusinersen). With the ongoing development aimed at optimizing outcomes for spinal muscular atrophy (SMA) patients, the study explores a higher dose regimen, which includes two loading doses of 50 mg followed by maintenance doses. Additionally, research on biomarkers and digital tools aims to enhance treatment strategies for SMA.

Biogen announced new findings regarding its multiple sclerosis (MS) therapies, particularly TYSABRI and VUMERITY, at the AAN 2021 Virtual Meeting. TYSABRI showed significant improvements in quality of life metrics compared to Ocrevus, with greater enhancements in areas like social roles and emotional management. Additionally, VUMERITY's gastrointestinal tolerability was validated in real-world settings, with a low discontinuation rate due to side effects. These findings reinforce Biogen's dedication to advancing MS treatment through innovative research and real-world evidence.

Biogen has received approval from China's National Medical Products Administration (NMPA) for TECFIDERA (dimethyl fumarate) to treat relapsing multiple sclerosis (MS). This well-established treatment has been administered to over 500,000 patients worldwide since its 2013 introduction. The approval, which followed a priority review, allows Biogen to expand its presence in China, where only about 10% of those diagnosed with MS receive disease-modifying therapies. Clinical trials show TECFIDERA significantly reduces annual relapse rates by 53% compared to placebo.

Biogen (Nasdaq: BIIB) is set to present the EMBARK trial design for its investigational Alzheimer’s therapy, aducanumab, at the 2021 AAN Annual Meeting on April 17, 2021. This Phase 3b, open-label study aims to evaluate the long-term safety and efficacy of aducanumab in Alzheimer’s patients. The presentation will be led by Dr. Carmen Castrillo-Viguera. More details can be accessed on Biogen's investor website, where an archived version will also be available post-event.

Aducanumab, a human monoclonal antibody, has shown promise in slowing cognitive decline in Alzheimer’s disease.

Sage Therapeutics and Biogen announced positive topline results from the Phase 2 KINETIC Study of SAGE-324 for essential tremor treatment. The study achieved its primary endpoint with a significant reduction in upper limb tremor score, showing a 36% decrease in the SAGE-324 group versus 21% in placebo (P=0.049). Severe tremor patients demonstrated an even greater 41% reduction. Safety profiles were consistent with previous data, and plans for further development of SAGE-324 are underway, reflecting the substantial unmet medical need in treating essential tremor affecting over 6.4 million in the U.S.

Biogen (Nasdaq: BIIB) announced the nomination of Dr. Maria C. Freire and William D. Jones for election to its board of directors during the 2021 annual meeting scheduled for June 2, 2021. Dr. Freire, currently with the National Institutes of Health Foundation, and Mr. Jones, CEO of CityLink Investment Corporation, bring diverse backgrounds in public health and business. The company expresses gratitude to retiring director Robert W. Pangia, who has been with the board since 1997. The nominations aim to enhance strategic perspectives and optimize capital allocation for stockholders.