BioAge Labs, Inc. - BIOA STOCK NEWS

BioArctic AB announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lecanemab as an Alzheimer's disease treatment in the EU. The recommendation applies to adult patients with early Alzheimer's who are apolipoprotein E ε4 heterozygotes or non-carriers. This follows a re-examination of CHMP's earlier negative recommendation, with European Commission's decision expected within 67 days. Lecanemab is already approved in multiple countries including the US, Japan, and China. BioArctic holds Nordic region commercialization rights, while partner Eisai handles development and commercialization elsewhere.

BioArctic AB announced that its partner Eisai has revised down its revenue forecast for Leqembi for fiscal year 2024 (April 2024-March 2025) to JPY 42.5 billion from JPY 56.5 billion previously announced in May. This adjustment would generate approximately SEK 300M in royalty for BioArctic. First-half FY2024 Leqembi sales reached JPY 16.3 billion, resulting in SEK 112.4M royalty to BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Biogen co-commercializing the product. BioArctic maintains Nordic region commercialization rights, pending European approval.

BioAge Labs reported Q3 2024 financial results and business updates. Key highlights include the initiation of Phase 2 STRIDES trial testing azelaprag with tirzepatide for obesity, and completion of a $238.3M IPO. The company reported R&D expenses of $20.0M (up from $6.5M in Q3 2023), G&A expenses of $4.7M, and a net loss of $23.4M. With approximately $334.5M in cash and cash equivalents, BioAge expects to fund operations into 2029. The company also appointed former GSK CEO Jean-Pierre Garnier as Board Chair.

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.