Axsome Therapeutics, Inc. announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA), supporting a supplemental NDA submission for AXS-05 in treating agitation associated with Alzheimer’s disease. The company plans to proceed with its submission based on this feedback.

A full press release detailing this development has been filed as an exhibit with the U.S. Securities and Exchange Commission.