Biogen Inc Stock Price, News & Analysis

Biogen (Nasdaq: BIIB) announced new data from its SMA research program, highlighting the first patient treated in the ASCEND study, which evaluates higher dose nusinersen for previously treated patients. The RESPOND study revealed nine infants with unmet needs after Zolgensma treatment, with no new safety concerns from SPINRAZA. Notable results from the NURTURE study showed that 92% of participants could walk independently, reinforcing the long-term benefits of early SPINRAZA treatment. These findings will be presented at the 2022 MDA Clinical & Scientific Conference.

Biogen (Nasdaq: BIIB) is set to present new research on Alzheimer’s disease and ADUHELM (aducanumab-avwa) at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022) from March 15-20 in Barcelona, Spain. Key presentations will include a plenary lecture on March 16 discussing ADUHELM’s effects on amyloid beta plaques and cognitive decline, and several oral presentations on March 18 covering recent analyses from Phase 3 clinical trials. Archived presentations will be available on Biogen’s investor website.

Eisai and Biogen announced the initiation of a submission to Japan's PMDA for lecanemab (BAN2401), an investigational antibody for Alzheimer's disease. The submission aims to utilize the 'prior assessment consultation' process to expedite application review. Eisai has submitted non-clinical data and plans to file for manufacturing and marketing approval in Japan during fiscal year 2022, contingent on data from the ongoing Clarity AD Phase 3 study expected in fall 2022. This follows a rolling submission to the U.S. FDA for lecanemab under the Accelerated Approval pathway.

Sage Therapeutics and Biogen announced that their CORAL Study achieved both primary and secondary endpoints in treating major depressive disorder (MDD) with zuranolone 50 mg. The trial demonstrated a statistically significant reduction in depressive symptoms at Day 3 and over a 2-week period compared to placebo. Participants reported adverse effects mostly mild or moderate, with no new safety signals. The results suggest zuranolone may accelerate the efficacy of existing antidepressants. A conference call will discuss the findings further.

Biogen and Xbrane Biopharma AB have entered a commercialization agreement to develop Xcimzane™, a proposed biosimilar referencing CIMZIA®, indicated for conditions such as rheumatoid arthritis and psoriasis. CIMZIA® generated €1.8 billion in 2020 sales. Biogen will handle global rights and make an upfront payment of $8 million to Xbrane, with potential milestones reaching $80 million. This collaboration aims to increase patient access to affordable treatments while bolstering Biogen's biosimilar pipeline.

Biogen has opted to participate in the development of mosunetuzumab, a bispecific antibody for treating B-cell non-Hodgkin’s lymphoma, by paying a $30 million option fee to Genentech. This investigational therapy targets CD20 and CD3, having received Breakthrough Therapy Designation from the FDA for adult patients with relapsed/refractory follicular lymphoma. Biogen will share in the operating profits in the low to mid 30% range and is eligible for royalties outside the U.S. Additionally, mosunetuzumab is in trials for systemic lupus erythematosus.

Biogen (Nasdaq: BIIB) announces the retirement of Board members Nancy Leaming and Brian Posner, effective at the 2022 annual meeting. Leaming, with a background in healthcare insurance, and Posner, a private investor, have served on the Board since 2008. Their contributions have been vital in guiding Biogen's mission in developing therapies for neurological diseases. The leadership expressed gratitude for their service, emphasizing the company's ongoing commitment to innovation in neuroscience and addressing climate health issues.

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.