Axsome Therapeutics Inc AXSM shares are trading higher Monday after the company received proposed labeling from the U.S. Food and Drug Administration for its treatment of major depressive disorder.
Axsome Therapeutics filed a Form 8-K with the U.S. Securities and Exchange Commission showing that it received proposed labeling for its AXS-05 product candidate with respect to its New Drug Application. The company is reviewing the proposed labeling and said it will reply to the FDA to secure the final labeling agreement.
Axsome Therapeutics is a biopharmaceutical company developing novel therapies for central nervous system conditions that have limited treatment options.
AXS-05 is the company's novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for major depressive disorder, Alzheimer's disease agitation and smoking cessation.
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AXSM Price Action: Axsome Therapeutics has traded between $74.10 and $19.38 over a 52-week period.
The stock was up 46% at $35.70 at press time, according to data from Benzinga Pro.
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