Axsome: FDA Accepts NDA Resubmission for Migraine Med

 Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.

https://www.globenewswire.com/news-release/2024/09/04/2940340/33090/en/Axsome-Therapeutics-Announces-FDA-Acceptance-of-NDA-Resubmission-for-AXS-07-for-the-Acute-Treatment-of-Migraine.html