प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णआवेदन स्वीकृत
Axsome: FDA ने कैटाप्लेक्सी में AXS-12 (reboxetine) की NDA स्वीकार की; PDUFA 1 मई 2027
FDA accepted the NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy. The agency set a PDUFA target action date of May 1, 2027 and stated it does not currently plan to hold an advisory committee meeting.
मुख्य तथ्य
- फाइल किया गया
- 15 जुल॰ 2026, 11:05 am
- घटना
- आवेदन स्वीकृत
- दिशा
- सकारात्मक
- कंपनी
AXSMAxsome- संपत्ति
- reboxetine
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 1 मई 2027
स्रोत का अंश
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee