Reboxetine (AXS-12) - (ENCORE)

July 15, 2026: Axsome Therapeutics, Inc. (NASDAQ: AXSM) said the FDA accepted for filing its New Drug Application (NDA) for AXS-12 (reboxetine) to treat cataplexy in narcolepsy. The FDA set a PDUFA target action date of May 1, 2027, and indicated it does not currently plan to convene an advisory committee meeting for the application. Axsome noted AXS-12 has FDA Orphan Drug Designation for narcolepsy and is not currently FDA-approved.