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 13, 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. ¨
Item 8.01. Other Events.
On April 13, 2021, Avenue Therapeutics, Inc. (“Avenue”), a Fortress Biotech Inc. partner company, announced that the Food and Drug Administration (the “FDA”) was still reviewing Avenue’s New Drug Application for IV tramadol (the “NDA”) and had not provided a decision regarding the NDA. In February 2021, the FDA indicated that Avenue’s resubmission of the NDA (the “Resubmission”) was a complete, class 1 response to the Complete Response Letter dated October 9, 2020, and that the Resubmission had been assigned a Prescription Drug User Fee Act goal date of April 12, 2021.
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.
| Fortress Biotech, Inc. |
| (Registrant) |
Date: April 13, 2021 | |
| | By: | /s/ Lindsay A. Rosenwald, M.D. |
| | | Lindsay A. Rosenwald, M.D. |
| | | Chairman, President and Chief Executive Officer |
