Axsome Therapeutics, Inc 8-K, filed Jan 18, 2022
Axsome Therapeutics, Inc. (AXSM)
About this 8-K
Axsome Therapeutics, Inc filed this 8-K on January 18, 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
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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.
Axsome Therapeutics, Inc. (the “Company”) has provided a response to the U.S. Food and Drug Administration (the “FDA”) addressing the two, previously disclosed, deficiencies related to analytical methods in the Chemistry, Manufacturing, and Controls section of the Company’s New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. At this time, Axsome has not been made aware of any other deficiencies related to the NDA by the FDA.
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.
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Axsome Therapeutics, Inc. |
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Date: |
January 18, 2022 |
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/s/ Herriot Tabuteau, M.D. |
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Name: Title:
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Herriot Tabuteau, M.D. |