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
November 28, 2017
Date of report (Date of earliest event reported)
Axsome Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware | | 001-37635 | | 45-4241907 |
(State or other jurisdiction
of incorporation) | | (Commission
File Number) | | (IRS Employer
Identification No.) |
25 Broadway, 9th Floor
New York, New York
(Address of principal executive offices) | | 10004
(Zip Code) |
Registrant’s telephone number, including area code (212) 332-3241
(Former name or former address, if changed since last report)
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
o 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 x
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. x
Item 8.01. Other Events.
On November 28, 2017, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing its next product candidate, AXS-07, which is being developed for the acute treatment of migraine. AXS-07 is an oral, fixed-dose combination of MoSEIC™ meloxicam and rizatriptan.
The Company has received Pre-Investigational New Drug Application written guidance from the U.S. Food and Drug Administration on a proposed clinical developmental plan for AXS-07, including a planned Phase 3 trial. Based on this feedback, the Company believes that only one Phase 3 trial may be needed for the approval of AXS-07 for the treatment of migraine. The Company anticipates starting this trial in 2018, contingent on the availability of resources. The U.S. Patent and Trademark Office recently issued patent number 9,821,075 which covers MoSEIC meloxicam and provides protection for AXS-07 into 2036.
The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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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.
| Axsome Therapeutics, Inc. |
| |
| |
Dated: November 28, 2017 | By: | /s/ Herriot Tabuteau, M.D. |
| Name: | Herriot Tabuteau, M.D. |
| Title: | President and Chief Executive Officer |
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