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): October 12, 2020
Avenue Therapeutics, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware (State or Other Jurisdiction of Incorporation) |
001-38114
|
|
47-4113275
|
1140 Avenue of the Americas, Floor 9
New York, NY 10036
(Address of Principal Executive Offices)
(781) 652-4500
(Registrant’s telephone number, including area code)
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 Exchange Act:
| Title of Class | Trading Symbol(s) | Exchange Name | ||
| Common Stock | ATXI | Nasdaq Capital Market |
| ¨ | 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. |
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 October 12, 2020, Avenue Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding its New Drug Application for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting. A copy of such press release is being furnished as Exhibit 99.1 to this report.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
The following exhibit is furnished herewith:
| Exhibit Number |
|
Description |
| 99.1 | Press release issued by Avenue Therapeutics, Inc., dated October 12, 2020. |
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: October 12, 2020 | ||
| By: | /s/ Lucy Lu, M.D. | |
| Lucy Lu, M.D. | ||
| President and Chief Executive Officer | ||