Longeveron(US:LGVN) Globenewswire·2025-09-22 13:15Core Insights - Longeveron Inc. is participating in the Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mesa from October 6-8, 2025, to explore partnerships for its Alzheimer's disease stem cell therapy program [1][2] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions [1][5] - The lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell therapy derived from the bone marrow of young, healthy adult donors [5] - The company is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, Pediatric Dilated Cardiomyopathy (DCM), and Aging-related Frailty [5] Alzheimer's Disease Program - Laromestrocel has shown promising results in a completed Phase 2a clinical trial (CLEAR MIND) for mild Alzheimer's disease, demonstrating an overall slowing of disease progression compared to placebo [3][6] - The trial met primary safety and secondary efficacy endpoints, with statistically significant improvements in clinical and biomarker outcomes for specific laromestrocel groups [3][7] - Full results from the CLEAR MIND study were presented at the 2024 Alzheimer's Association International Conference [4] Regulatory Designations - Laromestrocel has received multiple FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the HLHS program; and Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the Alzheimer's disease program [5][6] Clinical Development Pathway - A positive Type B meeting with the FDA in March 2025 established a clear regulatory pathway for a Biologics License Application (BLA) submission for laromestrocel in Alzheimer's disease [7] - The FDA has granted laromestrocel both RMAT and Fast Track designations, facilitating its development [6][7]