BIOA - BIOA STOCK NEWS

BioArctic and Eisai have signed a research evaluation agreement for BAN2802, a potential Alzheimer's treatment combining BrainTransporter™ technology with an undisclosed drug candidate. The collaboration aims to develop the next generation disease-modifying treatment for Alzheimer's disease. Eisai will evaluate the data to potentially license BAN2802, building on their successful partnership that led to the approval of Leqembi® for early Alzheimer's disease.

BioArctic AB's Nomination Committee proposes the election of board members and Chairperson for the upcoming Annual General Meeting. The proposed board consists of seven members, including a new member, Anna-Lena Engwall, with extensive experience in the life science and pharmaceutical industry. The Nomination Committee aims to enhance the board's expertise and network through these appointments.

BioArctic AB (NASDAQ: BIOA-B) included in Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index for its Sustainable Innovation approach. The company focuses on developing safe drugs against neurodegenerative diseases while integrating economic and environmental sustainability.

Eisai submits sBLA for monthly IV maintenance dosing of Leqembi for Alzheimer's disease treatment. The application is based on Phase 2b and Clarity AD studies data. Fast Track designation sought for SC formulation.

BioArctic AB's partner Eisai faces procedural delays at EMA for lecanemab review, impacting SAG-N meeting. The decision does not affect the Marketing Authorisation Application for lecanemab. BioArctic and Eisai collaborate on lecanemab development, with BioArctic having commercialization rights in the Nordic region.

BioArctic AB and Eisai present new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases. The data highlights the efficacy and safety of lecanemab in treating Alzheimer's disease, showing promising results in reducing Aβ protofibrils and plaques in the brain. The collaboration between BioArctic and Eisai has been instrumental in the development and regulatory submissions of lecanemab.

BioArctic AB's partner Eisai projects significant sales growth for Leqembi, an Alzheimer's disease treatment, with sales expected to reach JPY 290 billion in FY2026 and JPY 1.6 trillion in FY2032.

BioArctic AB (Nasdaq Stockholm: BIOA B) partner Eisai's Scientific Advisory Group (SAG) to discuss lecanemab's Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in Q1 2024. Eisai expects European Commission's decision in Q2 2024.

BioArctic AB's (Nasdaq Stockholm: BIOA B) partner Eisai announced that Leqembi has been approved in China as a treatment for mild cognitive impairment and mild AD dementia due to Alzheimer's disease. Leqembi is the first approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline. The drug is based on the large global Phase 3 Clarity AD study, where it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai estimates that there are 17 million patients with MCI or mild dementia due to AD in China today, which is expected to increase with the aging of the population. BioArctic has a long-term collaboration with Eisai regarding the development and commercialization for Leqembi. Eisai is responsible for the clinical development, applications for market approval, and commercialization of the drug. BioArctic has no development costs for Leqembi in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalties on global sales.