ProMIS Neurosciences Granted Fast Track Designation by U.S. FDA for PMN310 in the Treatment of Alzheimer’s Disease

Core Insights - The FDA has granted Fast Track designation to PMN310, a therapeutic candidate by ProMIS Neurosciences for Alzheimer's disease, highlighting its potential to address an unmet medical need [1][2][3] - PMN310 is designed to selectively target toxic oligomers of amyloid-beta, potentially reducing side effects associated with current treatments [3][5] - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310's safety, tolerability, and pharmacokinetics, with interim results expected in Q2 2026 [3][6] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's [1][7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins [7][8] Industry Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, indicating a significant need for effective treatments [4] - The Fast Track program by the FDA aims to expedite the development of therapies for serious conditions, which is crucial for addressing the urgent need for safer and more targeted Alzheimer's treatments [2][4]