[8-K] Fortress Biotech, Inc. Reports Material Event

Rhea-AI Filing Summary

Fortress Biotech, Inc. reported 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.

This disclosure highlights a defined regulatory timetable for CUTX-101, giving a clear date for when the FDA expects to take action on the resubmitted application, which is important context for anyone following the company’s drug development efforts.

Insights

Biotech regulatory analyst

FDA acceptance and PDUFA date establish a clear review timeline for CUTX-101.

The U.S. Food and Drug Administration accepted the resubmission of the New Drug Application for CUTX-101 as a Class 1 resubmission and provided a Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026. This combination of acceptance and a scheduled target action date is a key regulatory step for Fortress Biotech because it formalizes how CUTX-101 will be evaluated.

A defined PDUFA target action date can influence how stakeholders think about the timing of potential regulatory outcomes for CUTX-101. The period leading up to January 14, 2026 will be closely tied to the FDA’s review process and any subsequent decisions that shape the future of this program.

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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): December 15, 2025

Fortress Biotech, Inc.

(Exact Name of Registrant as Specified in Charter)

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Delaware
 (State or Other Jurisdiction
of Incorporation)   ​ ​ 001-35366
 (Commission File Number)   ​ ​ ​ 20-5157386
(IRS Employer
Identification No.)

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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:

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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

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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. ☐

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Item 8.01 Other Events.

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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.

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Item 9.01.    Financial Statements and Exhibits.

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(d)    Exhibits.

The following exhibit is furnished herewith:

99
Exhibit Number	​ ​ ​	Description
99.1		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)

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SIGNATURES

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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)
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Date: December 15, 2025
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	By:	/s/ David Jin
		David Jin
		Chief Financial Officer

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