FDA issues complete response letter on CUTX-101 for Fortress Biotech (FBIO)

Rhea-AI Filing Summary

Fortress Biotech, Inc. reported that the U.S. Food and Drug Administration has issued a complete response letter for CUTX-101 (copper histidinate). A complete response letter generally means the FDA has finished reviewing an application but cannot approve it in its present form. Fortress disclosed this development through a press release dated October 1, 2025, which is attached as an exhibit to the report.

Positive

• None.

Negative

• Regulatory setback for CUTX-101: The U.S. Food and Drug Administration issued a complete response letter for CUTX-101 (copper histidinate), indicating the application cannot be approved in its current form and may face delays.

Insights

Biopharmaceutical regulatory analyst

FDA complete response letter signals a setback for CUTX-101.

The company reports that the U.S. Food and Drug Administration issued a complete response letter for CUTX-101 (copper histidinate). A complete response letter indicates the agency has finished its review but requires changes or additional information before approving the application.

This type of regulatory feedback can delay potential commercialization of the product and may require further studies, analyses, or manufacturing or labeling changes, depending on the FDA’s specific comments. The filing does not provide those details, only noting that the press release contains more information.

The impact on Fortress Biotech will depend on the scope of issues raised in the letter and the company’s ability to address them, as described in the accompanying October 1, 2025 press release referenced in the exhibit list.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): October 1, 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 October 1, 2025, Fortress Biotech, Inc. issued a press release announcing that the U.S. Food and Drug Administration issued a complete response letter for CUTX-101 (copper histidinate). 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
99.1 104	​	Press release of Fortress Biotech, Inc., dated October 1, 2025. Cover Page Interactive Data File (embedded within 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: October 1, 2025
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	By:	/s/ David Jin
		David Jin
		Chief Financial Officer

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FAQ

What did Fortress Biotech (FBIO) disclose about CUTX-101 in this 8-K?

Fortress Biotech disclosed that the U.S. Food and Drug Administration issued a complete response letter for CUTX-101 (copper histidinate). This means the FDA completed review of the application but cannot approve it in its current form.

What is a complete response letter and how does it affect Fortress Biotech (FBIO)?

A complete response letter indicates the FDA finished reviewing an application but requires changes or more information before approving. For Fortress Biotech, this represents a regulatory setback for CUTX-101 and likely delays any potential approval timeline for that product.

Does the Fortress Biotech (FBIO) 8-K include details of the FDA’s concerns on CUTX-101?

The 8-K itself only states that the FDA issued a complete response letter for CUTX-101. Detailed information about the FDA’s feedback is contained in a press release dated October 1, 2025, attached as Exhibit 99.1 to the report.

Where can investors find more information about the CUTX-101 complete response letter for FBIO?

Additional information is available in Fortress Biotech’s press release dated October 1, 2025. That press release is furnished as Exhibit 99.1 to the report and is incorporated by reference for more context on the FDA decision.

Does this Fortress Biotech (FBIO) filing report any financial results or earnings?

No, this report does not present financial results or earnings data. It is focused on an "Other Events" disclosure, specifically that the U.S. Food and Drug Administration issued a complete response letter for CUTX-101 (copper histidinate).