Alpha Cognition Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the company's New Drug Application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer's Disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024. The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER.

Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed.