Every 8-K that Fortress Biotech, Inc. (FBIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow FBIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full FBIO filings page.
Fortress Biotech, Inc. (FBIO) repaid in full the remaining $15.0 million in principal under its Oaktree Agreement on September 30, 2026. It also paid approximately $435,000 in accrued interest, a $150,000 prepayment fee and other closing costs.
Following repayment, all indebtedness under the agreement was satisfied and paid in full, all liens and other security interests securing it were released and terminated, and the agreement automatically terminated pursuant to its terms.
Fortress Biotech, Inc. reported second-quarter 2026 net revenue of $18.7 million, a 14% increase over the same quarter in 2025. Product revenue reached $17.8 million, and total net revenue for the first six months of 2026 was $34.8 million, up from $29.6 million a year earlier.
Despite higher revenue, the quarter showed a net loss attributable to common stockholders of $2.5 million, compared with net income of $13.4 million in the prior-year quarter. For the first half of 2026, net income attributable to common stockholders was $105.9 million, driven largely by a $158.9 million gain from the sale of a priority review voucher and other investment-related items.
The balance sheet strengthened notably: cash and cash equivalents were $196.6 million as of June 30, 2026, up from $79.4 million at year-end 2025. Total assets rose to $316.7 million, while long-term notes payable declined to $34.6 million. Total stockholders’ equity increased to $206.1 million, from $62.2 million at December 31, 2025.
Fortress Biotech reported the results of its 2026 annual meeting of stockholders held virtually on June 17. Stockholders voted on electing seven directors to serve until the 2027 meeting and on ratifying KPMG LLP as independent registered public accounting firm for the year ending December 31, 2026.
Each director nominee, including Lindsay A. Rosenwald, Jimmie Harvey Jr., Malcolm Hoenlein, Dov Klein, J. Jay Lobell, Kevin L. Lorenz, and Michael S. Weiss, received more votes "For" than "Against." The proposal to ratify KPMG LLP also received substantially more votes "For" than "Against," based on the reported vote totals.
Fortress Biotech reported a sharp turnaround in the first quarter of 2026, driven by monetizing a Rare Pediatric Disease Priority Review Voucher for $205 million. This generated a gain on sale of $158.9 million and lifted net income attributable to common stockholders to $108.4 million, or $3.44 basic and $2.82 diluted EPS, compared with a loss a year earlier.
Net revenue rose to $16.0 million, up from $13.1 million, while operating loss narrowed as selling, general and administrative and research and development costs declined. Cash and cash equivalents increased to $255.8 million, and total stockholders’ equity grew to $202.4 million. Management highlighted FDA approval of ZYCUBO for Menkes disease, expected future royalties from ZYCUBO and UNLOXCYT, and debt reduction, including lowering Oaktree principal to $15.0 million, as key steps supporting its diversified portfolio strategy.
Fortress Biotech reported 2025 results showing a sharp improvement in profitability driven by asset monetizations and partner activity. Net revenue was $63.3 million for the year ended December 31, 2025, up from $57.7 million in 2024, mainly from product and other revenue.
Net income attributable to Fortress was $6.8 million, compared with a loss of $46.0 million in 2024, helped by a $27.1 million gain from deconsolidation of a subsidiary and $17.6 million of other income. Net loss attributable to common stockholders narrowed to $1.9 million, or $(0.07) per share.
Operationally, the FDA approved ZYCUBO for Menkes disease, and subsidiary Cyprium sold a Rare Pediatric Disease Priority Review Voucher for $205 million, with potential tiered royalties and up to approximately $128 million in sales milestones. The Checkpoint Therapeutics acquisition by Sun Pharma created eligibility for up to an additional $4.8 million under a contingent value right plus a 2.5% royalty on UNLOXCYT sales. Fortress also holds a 3% royalty on dotinurad sales through Crystalys Therapeutics.
Fortress Biotech reported that its majority-owned subsidiary Cyprium Therapeutics has closed the sale of its Rare Pediatric Disease Priority Review Voucher for $205 million in gross proceeds under a previously disclosed asset purchase agreement. In connection with the transaction, Cyprium redeemed all outstanding shares of its 9.375% Perpetual Preferred Stock.
Fortress, which owns 80.4% of Cyprium’s outstanding common stock on an as-converted basis, expects to receive at least $100.0 million from Cyprium through potential future dividends and intercompany agreements, including intercompany debt, interest and accrued expenses. Cyprium must pay 20% of the PRV sale proceeds to an institute of the National Institutes of Health and also remains eligible to receive tiered royalties on net sales of ZYCUBO and up to approximately $128 million in aggregate sales milestones from Sentynl Therapeutics.
Fortress Biotech’s majority-owned subsidiary Cyprium Therapeutics agreed to sell its FDA Rare Pediatric Disease Priority Review Voucher for $205 million in cash, payable at closing. The voucher was granted after ZYCUBO was approved to treat Menkes disease in pediatric patients.
Fortress owns 80.4% of Cyprium’s common stock and expects to receive at least $100 million over time from Cyprium through dividends and intercompany arrangements, subject to closing, taxes, required payments to a National Institutes of Health institute, Cyprium’s preferred stock redemption and other obligations. Fortress also amended its Oaktree credit agreement to ease several financial covenants after the PRV sale and to apply $10 million of proceeds, plus interest and a yield protection premium, to mandatory loan prepayment.
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.
Fortress Biotech, Inc. entered into a first amendment to its term loan credit agreement with Oaktree Fund Administration that extends the loan maturity, adjusts covenants and grants new stock warrants to the lenders. The company initially borrowed $35.0 million under the facility in July 2024 and currently has about $29.5 million outstanding.
The amendment moves the loan’s maturity from July 25, 2027 to June 30, 2028, with quarterly interest payments until maturity. Principal will be repaid based on the outstanding balance as of September 30, 2027: 12.5% due on September 30, 2027, another 12.5% on December 31, 2027, 37.5% on March 31, 2028, and the remaining 37.5% at maturity.
Journey Medical Corporation, a controlled subsidiary, is now subject to higher minimum product net sales covenants, rising from $60.0 million at December 31, 2025 to $80.0 million at December 31, 2026 and each quarter-end thereafter, with an event of default possible if these levels are not met while loan principal exceeds $10.0 million. In connection with the amendment, Fortress granted warrants to purchase up to 600,000 common shares at $2.62 per share, with anti-dilution and price-reset features, immediately exercisable through July 25, 2031 and issued as unregistered securities under Section 4(a)(2), with a planned resale registration.
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.
Fortress Biotech reports that its partner Sentynl Therapeutics has resubmitted the New Drug Application (NDA) for CUTX-101 to the U.S. Food and Drug Administration. CUTX-101 (copper histidinate) is intended to treat Menkes disease in pediatric patients and previously received a Complete Response Letter from the FDA on October 1, 2025. Sentynl, which assumed full responsibility for development and commercialization of CUTX-101 from Cyprium Therapeutics in December 2023, is leading the resubmission. Cyprium will retain ownership of any Priority Review Voucher that may be issued if the NDA is approved and is eligible to receive royalties and up to $129 million in aggregate development and sales milestone payments.
Fortress Biotech (FBIO) furnished an 8-K announcing it issued a press release with a corporate update and financial results for the quarter ended September 30, 2025. The press release is attached as Exhibit 99.1.
The company stated the information in this report, including Exhibit 99.1, is being furnished and shall not be deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference into Securities Act filings unless specifically referenced.
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.