Fortress Biotech (FBIO) Company Report

Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, announced on January 13, 2026, the U.S. FDA approval of ZYCUBO® (copper histidinate) for the treatment of Menkes disease in pediatric patients, making it the first and only approved treatment in the United States.
The FDA approval includes the grant of a Rare Pediatric Disease Priority Review Voucher (PRV), which will be transferred from Sentynl Therapeutics to Cyprium.
Cyprium Therapeutics is eligible to receive tiered royalties on net sales of ZYCUBO and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics.
Clinical efficacy results supporting the approval demonstrated a nearly 80% reduction in the risk of death for Menkes disease subjects who received early treatment with ZYCUBO compared to an untreated control group.

Jan 13, 2026, 2:19 PM

8-K

Fortress Biotech Amends Credit Agreement and Issues Warrants

FBIO

Debt Issuance

Guidance Update

Fortress Biotech, Inc. (FBIO) entered into an amendment to its credit agreement on December 12, 2025, extending the loan's maturity date and modifying principal repayment terms.
The loan's maturity date was extended from July 25, 2027, to June 30, 2028, with approximately $29.5 million currently outstanding.
A new financial covenant was established for its subsidiary, Journey Medical Corporation, requiring minimum product net sales of $60.0 million by December 31, 2025, increasing to $80.0 million by December 31, 2026, and each quarter thereafter.
In connection with the amendment, lenders were granted warrants to purchase up to 600,000 shares of common stock at $2.62 per share, exercisable immediately and expiring on July 25, 2031.

Dec 15, 2025, 9:33 PM

8-K

Fortress Biotech Announces FDA Acceptance of CUTX-101 NDA Resubmission

FBIO

Product Launch

New Projects/Investments

Fortress Biotech, Inc. (FBIO), through its majority-owned subsidiary Cyprium Therapeutics, announced the FDA's acceptance of the resubmission of the New Drug Application (NDA) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.
The resubmission has been accepted as a Class 1 resubmission, with a new Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026.
If approved, Cyprium is eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV), royalties on net sales, and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics, Inc., which resubmitted the NDA.

Dec 15, 2025, 1:30 PM

8-K

Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission

FBIO

New Projects/Investments

Guidance Update

The U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for CUTX-101, a treatment for Menkes disease in pediatric patients, from Fortress Biotech and its majority-owned subsidiary Cyprium Therapeutics.
The new Prescription Drug User Fee Act (PDUFA) target action date for the NDA is January 14, 2026.
The initial Complete Response Letter (CRL) from the FDA on September 30, 2025, cited observations regarding the manufacturing site's cGMP compliance but did not identify deficiencies in CUTX-101's efficacy and safety data.
Upon approval, Cyprium will receive a Rare Pediatric Disease Priority Review Voucher (PRV) and be eligible for royalties on net sales of CUTX-101, along with up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics.

Dec 15, 2025, 1:00 PM

Press Release

Fortress Biotech Reports Q3 2025 Financial Results and Corporate Updates

FBIO

Earnings

Revenue Acceleration/Inflection

M&A

Fortress Biotech reported a 20.5% increase in total net revenue, reaching $17.6 million for the third quarter ended September 30, 2025, compared to the same period in 2024.
The company achieved net income attributable to common stockholders of $3.7 million, or $0.13 per share basic, for Q3 2025, a significant improvement from a net loss in the prior year period.
Fortress received approximately $28 million upfront from the May 2025 acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma, with potential for additional contingent value rights and royalties.
Consolidated cash and cash equivalents increased to $86.2 million as of September 30, 2025, up $28.9 million year-to-date from December 31, 2024.
The New Drug Application (NDA) for CUTX-101 received a Complete Response Letter (CRL) from the FDA on September 30, 2025, citing cGMP deficiencies at the manufacturing facility, with resubmission expected shortly.

Nov 14, 2025, 1:35 PM

8-K

Fortress Biotech Reports Strong Q3 2025 Revenue Growth Driven by Emrosi Launch

FBIO

Earnings

Product Launch

Revenue Acceleration/Inflection

Fortress Biotech reported total revenues of $17.6 million for the third quarter of 2025, representing a 21% increase compared to the same period last year.
Emrosi contributed $4.9 million to the top line in Q3 2025, a 75% increase from Q2 2025, while Amzeeq achieved 146% total prescription growth to 18,198 prescriptions in Q3 2025.
The company achieved positive adjusted EBITDA of $1.7 million for Q3 2025 and anticipates becoming sustainably EBITDA positive in the fourth quarter of 2025.
GAAP net loss for Q3 2025 was $2.3 million, or $0.09 per share, and cash and cash equivalents totaled $24.9 million at the end of the quarter.

Nov 12, 2025, 9:30 PM

Transcript

Journey Medical Corporation Presents Positive Emrosi™ Phase 3 Clinical Trial Efficacy Data

FBIO

Product Launch

Journey Medical Corporation presented positive efficacy data from a pooled analysis of two Phase 3 clinical trials for its FDA-approved product, Emrosi™ (DFD-29), for the treatment of inflammatory lesions of rosacea in adults at the 2025 Fall Clinical Dermatology Conference.
In the Phase 3 studies, Emrosi demonstrated superior Investigator's Global Assessment (IGA) treatment success at Week 16, with 62.7% of subjects achieving success, compared to 39.0% for Oracea and 28.2% for placebo (p < 0.001 for all comparisons).
Emrosi also showed a greater mean reduction in inflammatory lesions from baseline to Week 16, with a reduction of 19.2 lesions, versus 14.8 for Oracea and 11.3 for placebo (p < 0.001 for all comparisons).
Emrosi is available by prescription at specialty pharmacy chains and was well tolerated in trials with no major safety issues or serious adverse events related to the study drug.

Oct 24, 2025, 12:30 PM

Press Release

Fortress Biotech Faces Investigation Following FDA CRL for CUTX-101

FBIO

Legal Proceedings

The Portnoy Law Firm has initiated an investigation into Fortress Biotech Inc. (FBIO) for possible securities fraud, which may lead to a class action lawsuit on behalf of investors.
This investigation follows the October 1, 2025, announcement by Fortress and its subsidiary, Cyprium Therapeutics, Inc., that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for CUTX-101.
The CRL specifically noted cGMP deficiencies observed at the facility where CUTX-101 is manufactured.
Following this news, the price of Fortress Biotech’s stock dropped.

Oct 1, 2025, 7:45 PM

Press Release

Fortress Biotech and Cyprium Therapeutics Receive FDA Complete Response Letter for CUTX-101 NDA

FBIO

Product Launch

Fortress Biotech, Inc. and its majority-owned subsidiary, Cyprium Therapeutics, Inc., announced on October 1, 2025, that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients.
The CRL noted cGMP deficiencies observed at the manufacturing facility during a September 2025 re-inspection.
The FDA's CRL did not cite any other approvability concerns or identify deficiencies in CUTX-101's efficacy and safety data.
Sentynl Therapeutics, Inc., the partner responsible for CUTX-101, expects to request a meeting with the FDA to address the concerns and pursue a prompt resubmission of the NDA.
Upon approval, Cyprium is eligible to receive a Rare Pediatric Disease Priority Review Voucher (PRV), royalties on net sales, and up to $129 million in aggregate development and sales milestones from Sentynl.

Oct 1, 2025, 12:45 PM

8-K

Fortress Biotech Announces Crystalys Therapeutics' $205 Million Series A Financing

FBIO

New Projects/Investments

M&A

Crystalys Therapeutics, in which Fortress Biotech's subsidiary Urica Therapeutics holds an equity position, closed a $205 million Series A financing round on October 1, 2025, to support the advancement of global Phase 3 clinical studies for dotinurad, a treatment for gout.
Urica Therapeutics sold dotinurad to Crystalys in 2024 and is eligible to receive a 3% royalty on future net sales of dotinurad, in addition to its minority equity position and the right to appoint a board member to Crystalys.
Dotinurad is a next-generation URAT1 inhibitor that has demonstrated robust efficacy and a well-defined safety profile, leading to its approval in Japan, China, Philippines, and Thailand.
Fortress Biotech also highlighted the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma earlier this year, which delivered approximately $28 million upfront, with potential for additional contingent value right payments and ongoing royalties.