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): July 27, 2021
Fortress Biotech, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware (State or Other Jurisdiction of Incorporation) | | 001-35366 (Commission File Number) | | 20-5157386 (IRS Employer Identification No.) |
2 Gansevoort Street, 9th Floor
New York, New York 10014
(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:
| ¨ | 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 each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock | FBIO | Nasdaq Capital Market |
| 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock | FBIOP | 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. ¨
On July 27, 2021, Avenue Therapeutics, Inc. (“Avenue”) a Fortress Biotech, Inc. partner company, submitted a Formal Dispute Resolution Request (“FDRR”) to the Food and Drug Administration (“FDA”) with respect to the Complete Response Letters (together, the “CRLs”) previously issued by the FDA to Avenue related to its intravenous (“IV”) tramadol New Drug Application (“NDA”). The submission of the FDRR follows a Post-Action Type A meeting with the FDA that did not resolve the issues identified in the CRLs. The regulatory history of the NDA for IV tramadol, the anticipated FDRR process and other pertinent information regarding these topics were previously disclosed.
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: July 29, 2021 | | | |
| | By: | /s/ Lindsay A. Rosenwald, M.D. | |
| | | Lindsay A. Rosenwald, M.D. | |
| | | President and Chief Executive Officer | |
