symbravo — NDA/BLA filed

“On August 19, 2025, Axsome Therapeutics, Inc. (the "Company") received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Apotex Inc. ("Apotex"), providing notification to the Company that Apotex has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture, use, or sell a generic version of Symbravo ® (meloxicam-rizatriptan benzoate).”