FDA approves ZYCUBO for Menkes at Fortress Biotech (NASDAQ: FBIO)

Rhea-AI Filing Summary

Fortress Biotech, Inc. reported that the U.S. Food and Drug Administration approved ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients. This represents regulatory clearance for a therapy aimed at a rare pediatric condition.

In connection with this FDA approval, a Rare Pediatric Disease Priority Review Voucher was issued and will be transferred to Cyprium Therapeutics, Inc., a majority-owned subsidiary of Fortress Biotech. The company furnished a press release with further details as an exhibit.

Positive

• FDA approval of ZYCUBO for treating Menkes disease in pediatric patients provides regulatory clearance for a new rare pediatric therapy.
• A Rare Pediatric Disease Priority Review Voucher was issued in connection with the approval and will be transferred to majority-owned subsidiary Cyprium Therapeutics, highlighting an additional regulatory asset.

Negative

• None.

Insights

Biotech regulatory analyst

FDA approval of ZYCUBO and issuance of a rare pediatric voucher mark a significant regulatory milestone for Fortress Biotech.

The company reports FDA approval of ZYCUBO (copper histidinate) to treat Menkes disease in pediatric patients. FDA approval typically follows extensive clinical and regulatory review, so this step confirms that the product met the agency’s standards for this rare pediatric indication.

The approval also triggered issuance of a Rare Pediatric Disease Priority Review Voucher, which will be transferred to majority-owned subsidiary Cyprium Therapeutics, Inc.. Priority review vouchers are recognized regulatory assets because they can be applied to accelerate review of a future application or used in other ways as allowed by regulation. The filing indicates this development through an attached press release, with further details expected there.

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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):  January 13, 2026

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 January 13, 2026, Fortress Biotech, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) approved ZYCUBO® (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric patients. A Rare Pediatric Disease Priority Review Voucher (“PRV”) was issued in connection with the FDA approval and will be transferred to Cyprium Therapeutics, Inc. (“Cyprium”), a majority-owned subsidiary of the Company. 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 January 13, 2026
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: January 13, 2026
​	​	​
	By:	/s/ David Jin
		David Jin
		Chief Financial Officer

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FAQ

What did Fortress Biotech (FBIO) announce in this 8-K?

Fortress Biotech announced that the U.S. Food and Drug Administration approved ZYCUBO (copper histidinate) for the treatment of Menkes disease in pediatric patients, and that a Rare Pediatric Disease Priority Review Voucher was issued in connection with this approval.

What is ZYCUBO and what condition does it treat for FBIO?

ZYCUBO, also referred to as copper histidinate and formerly known as CUTX-101, is approved by the FDA for the treatment of Menkes disease in pediatric patients.

What is the Rare Pediatric Disease Priority Review Voucher mentioned by Fortress Biotech?

In connection with the FDA approval of ZYCUBO, a Rare Pediatric Disease Priority Review Voucher was issued. The filing notes that this voucher is tied to the rare pediatric disease program and arose from the ZYCUBO approval.

Who will receive the Rare Pediatric Disease Priority Review Voucher from the ZYCUBO approval?

The Rare Pediatric Disease Priority Review Voucher issued in connection with ZYCUBO’s FDA approval will be transferred to Cyprium Therapeutics, Inc., which is described as a majority-owned subsidiary of Fortress Biotech.

Where can investors find more details about FBIO’s ZYCUBO approval?

More details are contained in the press release that Fortress Biotech issued on January 13, 2026, which is attached as Exhibit 99.1 to this report and incorporated by reference.

Does this 8-K discuss any financial results for Fortress Biotech (FBIO)?

No, this report focuses on the FDA approval of ZYCUBO and the related Rare Pediatric Disease Priority Review Voucher, and does not present financial results.