BioAge Labs, Inc. - BIOA STOCK NEWS

BioArctic AB has unveiled its proprietary BrainTransporter (BT) platform at the PEGS conference in Barcelona. The technology demonstrates up to 70-fold higher penetration of antibodies across the blood-brain barrier using Transferrin Receptor-mediated transport, without negative effects on hematological safety. The platform shows rapid, broad, and deep distribution of amyloid-beta antibodies across the brain in preclinical models. In April 2024, BioArctic and Eisai entered a research evaluation agreement for BAN2802, combining BT technology with an Alzheimer drug candidate.

BioArctic AB (NASDAQ STOCKHOLM: BIOA B) has announced it will release its Q3 2024 report for July-September on November 14, 2024, at 08:00 CET. The company will host an audiocast with teleconference in English at 09:30 CET where CEO Gunilla Osswald and CFO Anders Martin-Löf will present the quarterly results and conduct a Q&A session. Participants can join via webcast or teleconference, with both options requiring pre-registration. The presentation will be available on-demand afterward on BioArctic's corporate website.

BioAge Labs announced new preclinical data presentations for azelaprag, their oral APJ agonist, at ObesityWeek 2024. The studies demonstrated that azelaprag enhanced weight loss when combined with various appetite suppressants in obese mice on high-fat diets. As a monotherapy, azelaprag showed protection against excess weight gain, improved body composition, and increased physical activity and energy expenditure. The data supports azelaprag's potential as a novel obesity treatment, both as a standalone therapy and in combination with other medications like semaglutide, tirzepatide, danuglipron, and rimonabant.

BioArctic AB's partner Eisai has completed a rolling Biologics License Application (BLA) submission to the FDA for Leqembi subcutaneous autoinjector for weekly maintenance dosing in early Alzheimer's disease treatment. The autoinjector would allow for 15-second home administration after completing the initial IV phase. The application is based on Clarity AD open-label extension study data. Leqembi is currently approved in multiple countries including the US, Japan, and China, with pending applications in 10 other regions. The FDA is also reviewing a separate application for monthly IV maintenance dosing with a PDUFA date of January 25, 2025.

BioArctic AB (NASDAQ Stockholm: BIOA B) partner Eisai presented three-year data for lecanemab (Leqembi®) at CTAD congress, showing increased benefits for early Alzheimer's patients. The drug demonstrated a 30% reduction in disease stage progression risk, with 46% of patients with low brain amyloid levels showing improved or maintained cognition after three years. The CDR-SB benefit expanded to -0.95 compared to ADNI-population at 36 months. Safety profile remained consistent, with most ARIA occurring in first six months. Data suggests continued treatment benefits even after plaque clearance, particularly in early-stage patients. In Great Britain's approved population, treatment showed 33% CDR-SB decline slowing versus 27% in total study population.

BioArctic AB's partner Eisai reported Leqembi® global revenue of JPY 10 billion for Q3 2024, marking a 60% increase from Q2 2024's JPY 6.3 billion. This resulted in a royalty payment of approximately SEK 70 million to BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Biogen co-commercializing the product. BioArctic maintains commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai pending European approval.

BioArctic AB announced that its co-founder, Professor Lars Lannfelt, received the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the CTAD congress in Madrid. The award recognizes his pioneering work in Alzheimer's disease research and drug development, particularly his contributions leading to lecanemab, a disease-modifying treatment for early Alzheimer's approved in multiple countries including the U.S., Japan, and China. Lannfelt founded BioArctic in 2003 with Pär Gellerfors to develop antibody treatments based on his discoveries about amyloid-beta protein's role in Alzheimer's disease. Lecanemab, developed in collaboration with Eisai, works by binding to and clearing specific forms of amyloid-beta from the brain.

BioAge Labs (Nasdaq: BIOA), a clinical-stage biopharmaceutical company focused on developing therapeutics for metabolic diseases through aging biology, has announced its participation in the Jefferies London Healthcare Conference. CEO and co-founder Kristen Fortney, PhD, will deliver a presentation at the conference, scheduled for November 19-21, 2024. The presentation will be available on-demand, with a live webcast scheduled for November 19 at 1:00-1:25 PM GMT. Interested parties can access the presentation replay through BioAge's investor relations website for approximately 30 days post-conference.

BioArctic AB announced that its founder, Lars Lannfelt, will receive the Lifetime Achievement Award in Alzheimer's Disease Therapeutic Research at the CTAD Conference in Madrid from October 29 to November 1. The conference will feature presentations on lecanemab, including data on its clinical practice use and plasma biomarkers in the AHEAD 3-45 trial. Key sessions include three symposia focusing on lecanemab's continued treatment importance, real-world evidence from the U.S. and Japan, and combination therapy considerations. Two oral presentations will discuss lecanemab's treatment efficacy and AI-derived prognostic covariates, along with a poster presentation on transitioning from clinical trials to practice.