Axsome Says FDA Finds Deficiencies With AXS-05 Application

 Axsome Therapeutics Inc. on Monday said the U.S. Food and Drug Administration has flagged deficiencies related to the company's AXS-05 new drug application that could delay approval of the proposed treatment of major depressive disorder, sending shares of the biopharmaceutical company tumbling in premarket trading.

New York-based Axsome said the FDA recently notified the company that it had found unspecified deficiencies that currently preclude the discussion of labeling and post-marketing requirements and commitments.

Axsome said it is attempting to learn the nature of the deficiencies with the goal of addressing them, but it said the development may lead to a delay in the potential approval of AXS-05.

The FDA in April granted priority review to AXS-05 for the treatment of major depressive disorder and set a target action date of Aug. 22 for the application.

Axsome is also studying AXS-05 in Alzheimer's disease agitation and smoking cessation.

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