प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णPDUFA तारीख़ तय
अल्ज़ाइमर एजिटेशन के लिए AXS-05 की sNDA स्वीकृत, PDUFA तिथि 30 अप्रैल 2026
FDA accepted the supplemental NDA for AXS-05 in Alzheimer’s agitation and granted Priority Review, setting a PDUFA target action date of April 30, 2026. The filing is supported by four Phase 3 trials and a long-term safety study. Priority Review shortens the FDA review clock to six months.
मुख्य तथ्य
- फाइल किया गया
- 31 दिस॰ 2025, 12:10 pm
- घटना
- PDUFA तारीख़ तय
- दिशा
- तटस्थ
- कंपनी
AXSMAxsome- संपत्ति
- AXS-05
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 30 अप्रैल 2026 · मंज़ूर
स्रोत का अंश
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission New Drug Application (NDA) submission on track for January 2026 NEW YORK, December 31, 2025 (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 it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting an NDA submission for AXS-12 in narcolepsy. AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. The purpose of the meeting was to reach agreement with the
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