Biogen Inc Stock Price, News & Analysis

Biogen Inc. (Nasdaq: BIIB) has finalized a deal with Samsung Biologics for the sale of its equity stake in the Samsung Bioepis joint venture for up to $2.3 billion. This includes an immediate cash payment of $1 billion and deferred payments totaling $1.25 billion over two years. Biogen will maintain commercial rights for certain biosimilars, including BYOOVIZ and an investigational candidate, SB15. This move is viewed as a significant step in continuing Biogen's portfolio and enhancing financial flexibility.

Biogen and Eisai announced details of the ENVISION Phase 4 study of ADUHELM for early Alzheimer’s disease, aiming for 1,500 participants, inclusive of 18% from Black/African American and Latinx backgrounds. This initiative emphasizes diversity in clinical trials, essential for relevant data. The study's primary endpoint will assess cognitive function after 18 months, utilizing CDR-SB. While the trial progresses, Biogen faces potential Medicare coverage restrictions for ADUHELM. The patient screening is set to begin in May 2022.

Biogen has exercised its option to obtain a worldwide, exclusive license for BIIB115, a preclinical investigational antisense oligonucleotide aimed at treating spinal muscular atrophy (SMA). This includes a $60 million upfront payment to Ionis Pharmaceuticals. BIIB115 is intended to address unmet needs in SMA treatment and has potential for extended dosing intervals. Biogen will handle all development costs, including future milestone payments and royalties on net sales. BIIB115 may significantly enhance treatment options for SMA patients.

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.