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): December 15, 2025
Fortress Biotech, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware | | 001-35366 | | 20-5157386 |
1111 Kane Concourse, Suite 301
Bay Harbor Islands, FL 33154
(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 December 15, 2025, Fortress Biotech, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 as a Class 1 resubmission and provided a Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026 for the NDA. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
99 | ||
Exhibit | | Description |
| Press release of Fortress Biotech, Inc. dated December 15, 2025. | |
104 |
| Cover Page Interactive Data File (the cover page XBRL tags are imbedded in the 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.
| Fortress Biotech, Inc. | |
| (Registrant) | |
| | |
Date: December 15, 2025 | ||
| | |
| By: | /s/ David Jin |
|
| David Jin |
|
| Chief Financial Officer |