FDA flags Axsome NDA for lead candidate

Aug. 9, 2021

Axsome Therapeutics revealed that the U.S. FDA has flagged deficiencies related to the company's AXS-05 new drug application that could delay approval of the experimental treatment for major depressive disorder.

While reporting its second-quarter financial results, 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.

According to the company's CEO, Herriot Tabuteau, "We are attempting to learn the nature of these deficiencies with the goal of addressing them, however, this development may lead to a delay in the potential approval of AXS-05."

Some investors have expressed concern that the deficiencies letter from the U.S. regulator, sent to the company on July 30, could lead to a formal CRL.

AXS-05, Axsome’s lead candidate and potential blockbuster, is a novel, oral, investigational NMDA receptor antagonist. In April, the FDA granted priority review to drugs for the treatment of major depressive disorder and set a target action date of Aug. 22 for the application.

The company is also developing the drug for Alzheimer’s disease agitation and smoking cessation.

Axsome has promised to keep the public informed as the company learns more from the FDA regarding the deficiencies.