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Item 7.01 Regulation FD Disclosure.
Axsome Therapeutics, Inc. (the “Company”) remains on track and is in the process of submitting a New Drug Application (“NDA”) for AXS-05 in major depressive disorder, expected imminently. The Company intends to issue a press release following the U.S. Food and Drug Adminstration’s decision regarding its acceptance of the filing.
The information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Axsome Therapeutics, Inc.
Dated: January 28, 2021
/s/ Herriot Tabuteau, M.D.
Herriot Tabuteau, M.D.
President and Chief Executive Officer