Axsome Therapeutics NDA for AXS-12 accepted by FDA; PDUFA date May 1, 2027

Axsome Therapeutics announced the FDA has accepted its NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy with a PDUFA date of May 1, 2027.

Key Highlights:

• FDA accepted filing of the New Drug Application for AXS-12 for treatment of cataplexy in narcolepsy.
• PDUFA target action date set for May 1, 2027, establishing the regulatory review timeline.
• FDA indicated it does not currently plan to hold an advisory committee meeting for the application.
• AXS-12 has U.S. FDA Orphan Drug Designation; AXS-12 is not yet FDA approved.

Original SEC Filing:

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.