Biogen Inc. - BIIB STOCK NEWS

Biogen and Ionis Pharmaceuticals announced a strategic collaboration whereby Biogen exercised its option to acquire a worldwide, exclusive license to develop and commercialize BIIB115/ION306, an investigational antisense oligonucleotide targeting spinal muscular atrophy (SMA). This initiative aims to address unmet patient needs and is supported by a $60 million upfront payment from Biogen. Plans include advancing BIIB115 into clinical trials to evaluate its safety and efficacy, with Biogen handling all development costs.

On December 23, 2021, Eisai and Biogen announced that their investigational Alzheimer's treatment, lecanemab, received Fast Track designation from the U.S. FDA. This designation aims to expedite development for drugs addressing serious conditions. Lecanemab has previously been granted Breakthrough Therapy designation in June 2021. The ongoing Phase 3 Clarity AD study includes 1,795 patients, with results expected to confirm clinical benefits. Lecanemab targets amyloid-beta aggregates, showing promise in reducing clinical decline based on Phase 2 results.

Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. announced that Japan's First Committee on New Drugs (NDC) will continue deliberations on the application for aducanumab, aimed at treating Alzheimer’s disease. The NDC has requested additional data for the manufacturing and marketing approval process. Both companies are committed to collaborating with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) to meet these requirements. Aducanumab, a monoclonal antibody, targets amyloid beta in Alzheimer’s patients.

Biogen Inc. announced a 50% reduction in the wholesale acquisition cost of ADUHELM (aducanumab-avwa) effective January 1, 2022, aiming to enhance patient access to Alzheimer’s treatment. The average yearly expense per patient will be approximately $28,200. The company's CEO emphasized the importance of sustainability for the U.S. healthcare system. Additionally, Biogen will implement cost-reduction strategies to align costs with revenue, expecting to achieve $500 million in annual savings, partially offset by pipeline investments. This move comes amid ongoing discussions regarding CMS coverage for ADUHELM.

Biogen Inc. (Nasdaq: BIIB) and Eisai have announced a negative opinion from the CHMP regarding the Marketing Authorization Application for aducanumab, aimed at treating early-stage Alzheimer’s disease. This follows a prior negative vote in November 2021. Biogen will seek a re-examination to address the committee's concerns. The MAA included data from a multi-study program involving approximately 3,600 patients across over 20 countries. Notably, ADUHELM received accelerated approval from the FDA in June 2021. The situation reflects ongoing challenges in Alzheimer's treatment approval.

Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. announce progress on the Phase 4 post-marketing confirmatory study of ADUHELM (aducanumab-avwa) for Alzheimer’s disease. The final protocol will be submitted to the FDA by March 2022, followed by patient screening in May 2022. The global, placebo-controlled trial aims to enroll over 1,300 patients with an expected primary completion in four years. This study is a requirement of the FDA's accelerated approval for ADUHELM, which targets amyloid beta plaques in Alzheimer’s patients.

Biogen (Nasdaq: BIIB) has announced a collaboration with TheraPanacea to utilize machine learning and artificial intelligence in neurology. This partnership aims to enhance patient care, streamline drug development, and deepen understanding of neurological diseases. Biogen will invest up to $15 million and can earn up to $41 million in milestone payments based on R&D achievements. The collaboration grants Biogen exclusive rights to TheraPanacea's technology in neuroscience, promoting a new era in personalized medicine.

Sage Therapeutics and Biogen announced promising results from their clinical program for zuranolone, an investigational treatment for major depressive disorder (MDD). In the WATERFALL Study, patients receiving 50 mg zuranolone showed rapid improvements in depressive symptoms as early as Day 3, with effects maintained through Day 42. Safety profiles were consistent with previous studies, showing no increase in adverse events typical of existing antidepressants. Results for older patients (65+) were similarly favorable. These findings were presented at the American College of Neuropsychopharmacology Congress.

Sage Therapeutics and Biogen have announced positive 12-month results for zuranolone 50 mg in the ongoing Phase 3 SHORELINE Study. The study included 199 patients with major depressive disorder (MDD), demonstrating that 74.9% responded to the initial treatment. Zuranolone was well-tolerated, with 68.8% reporting adverse events, mostly mild to moderate. Approximately 80% of responders received just one or two treatment courses over a year, showcasing the drug's potential for quick symptom relief without frequent dosing.