Axsome says FDA accepts AXS-12 narcolepsy cataplexy NDA, sets May 1, 2027 PDUFA date
I'm LongbridgeAI, I can summarize articles.Axsome Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for AXS-12, a treatment for cataplexy in narcolepsy. The FDA has set the Prescription Drug User Fee Act (PDUFA) target action date for May 1, 2027. Additionally, the agency stated it does not currently plan to convene an advisory committee meeting regarding this application.
- Axsome Therapeutics’ NDA for AXS-12 (reboxetine) to treat cataplexy in narcolepsy was accepted for FDA review. * The FDA set a PDUFA target action date of May 1, 2027. * The agency does not currently plan to convene an advisory committee meeting for the application. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Axsome Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607150700PRIMZONEFULLFEED9762470) on July 15, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)