Alpha Cognition's ALPHA-1062 Receives FDA Nod for Mild-to-Moderate Alzheimer's
Alpha Cognition Inc., a pioneering biopharmaceutical company dedicated to developing innovative therapeutics for debilitating neurodegenerative disorders, is pleased to inform stakeholders that the U.S. Food and Drug Administration (FDA) has successfully completed its comprehensive review of the New Drug Application (NDA) for ALPHA-1062. This novel therapeutic solution represents a proprietary, patented, delayed-release oral tablet formulation specifically designed for the treatment of individuals grappling with mild-to-moderate Alzheimer's Disease.
The momentous acceptance of the NDA signifies a significant milestone in the drug development process, marking a crucial step toward potentially introducing an effective treatment option for those affected by this challenging neurodegenerative condition. The Prescription Drug User Fee Act (PDUFA) has assigned a goal date for the application, with expectations set for culmination on July 27th, 2024.