Axsome Therapeutics, Inc 8-K, filed Apr 25, 2022
Axsome Therapeutics, Inc. (AXSM)
About this 8-K
Axsome Therapeutics, Inc filed this 8-K on April 25, 2022, reporting on events of April 22, 2022.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 8.01 Other Events.
On April 22, 2022, Axsome Therapeutics, Inc. (the “Company”) was informed by the U.S. Food and Drug Administration (the “FDA”) that chemistry, manufacturing, and controls (“CMC”) issues identified during the FDA’s review of the Company’s New Drug Application (“NDA”) for its AXS-07 product candidate for the acute treatment of migraine are unresolved. Based upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.
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 thereunto duly authorized.
|
|
|
Axsome Therapeutics, Inc. |
|
|
|
|
Date: |
April 25, 2022 |
By: |
/s/ Herriot Tabuteau, M.D. |
|
|
Name: Title: |
Herriot Tabuteau, M.D. |