Why Axsome Therapeutics Stock Is Crashing Today

Shares of Axsome Therapeutics (NASDAQ: AXSM), a mid-cap biotech, are down by a hefty 41.4% as of 10:08 a.m. EDT Monday morning. The drugmaker's shares are tumbling today in response to a disappointing regulatory update for AXS-05 as a potential treatment for major depressive disorder (MDD). 

Specifically, Axsome revealed during its 2021 second-quarter earnings release this morning that the U.S. Food and Drug Administration (FDA) had notified the company on July 30, 2021 that it has identified deficiencies within the drug's regulatory application that preclude discussion of labeling and post-marketing requirements at this time. A final decision on AXS-05's regulatory review for MDD is currently slated for Aug. 22, 2021.

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Source Fool.com