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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

 

Date of report (Date of earliest event reported): April 17, 2023

 

Avenue Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware
(State or Other Jurisdiction
of Incorporation)

001-38114
(Commission File Number)

 

47-4113275
(IRS Employer Identification No.)

 

 

1111 Kane Concourse, Suite 301

Bay Harbor Islands, Florida 33154

(Address of Principal Executive Offices)

 

(781) 652-4500

(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:

 

¨ Written communications pursuant to Rule 425 under the Securities Act.
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act.
   
¨ Pre-commencement communications pursuant to Rule 14d-2b under the Exchange Act.
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

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

 

Title of Class Trading Symbol(s) Name of each exchange on which
registered
Common Stock ATXI Nasdaq Capital Market

 

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). ¨

 

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 17, 2023, Avenue Therapeutics, Inc. issued a press release announcing the receipt of official meeting minutes from the U.S. Food and Drug Administration regarding a meeting conducted on March 9, 2023, for intravenous Tramadol. A copy of such press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The following exhibits are furnished herewith:

 

Exhibit
Number
  Description
     
99.1   Press Release dated April 17, 2023
104   Cover Page Interactive Data File (embedded within Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  AVENUE THERAPEUTICS, INC.
 

(Registrant)

Date: April 17, 2023

 
  By:  /s/ David Jin  
    David Jin  
    Interim Principal Financial Officer and Chief Operating Officer