​

​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

​

​

FORM 8-K

​

​

CURRENT REPORT

Pursuant to Section 13 or 15(D)

of the Securities Exchange Act of 1934

​

January 28, 2021

Date of report (Date of earliest event reported)

​

​

Axsome Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

​

​

​

​

Registrant’s telephone number, including area code (212) 332-3241

​

(Former name or former address, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:
​

​

​

Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

​

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

​

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

​

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

​

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

​

​

​

​

​

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.

​

​

​

SIGNATURES

​

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.

​

​

​

​

​