Welcome to our dedicated page for Fortress Biotech SEC filings (Ticker: FBIO), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Fortress Biotech, Inc. (Nasdaq: FBIO) SEC filings page on Stock Titan provides access to the company’s regulatory documents filed with the U.S. Securities and Exchange Commission. These filings include current reports on Form 8-K, registration statements such as Form S-1, and other periodic disclosures that describe material events, financing arrangements and portfolio developments across Fortress and its subsidiaries.
Recent Form 8-K filings detail items such as amendments to the company’s credit agreement with Oaktree Fund Administration, LLC, including an extension of the loan maturity date and revised financial covenants tied to product net sales at Journey Medical Corporation. They also describe the issuance of warrants to purchase shares of Fortress common stock, with terms such as exercise price, anti-dilution adjustments and expiration date. Other 8-Ks report FDA-related milestones, including the issuance of a Complete Response Letter for CUTX-101, subsequent resubmission of the New Drug Application by Sentynl Therapeutics, and Fortress’ press releases on quarterly financial results.
The Form S-1 registration statement reproduced in part here explains Fortress Biotech’s business model, outlines its network of subsidiaries and partner companies, and registers the resale of shares issuable upon exercise of warrants granted in connection with its credit facility. It also describes risk factors, forward-looking statements and other information relevant to investors evaluating FBIO securities.
On Stock Titan, these SEC filings are complemented by AI-powered summaries that highlight key terms, financial obligations and corporate actions, helping readers quickly understand the implications of documents that can span many pages. Users can review filings related to common stock and preferred stock listed on the Nasdaq Capital Market, as well as disclosures about royalty arrangements, subsidiary transactions and regulatory events that may affect Fortress Biotech’s capital structure and operations.
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. filed Amendment No. 8 to its Schedule 13D for Avenue Therapeutics, Inc., reporting beneficial ownership of 439,955 shares of Avenue common stock, equal to 13.4% of the outstanding common shares. This total includes 250,000 shares of Class A preferred stock, which are convertible into 222 shares of common stock and are structured so that the Class A preferred will at all times constitute a voting majority. Fortress owns all outstanding Class A preferred shares, giving it majority voting control despite a minority economic stake.
Fortress’s ownership also reflects an Annual Equity Grant under a Founders Agreement, through which Avenue issues to Fortress each year shares equal to 2.5% of Avenue’s fully diluted outstanding equity. In addition, as holder of the Class A preferred, Fortress is entitled each January 1 to stock dividends in Avenue common equal to 2.5% of Avenue’s fully diluted outstanding capitalization. The filing notes 296 Avenue common shares underlying outstanding warrants granted by Fortress to two of its executives, with Fortress retaining sole voting power but shared dispositive power over those warrant shares.
Fortress Biotech, Inc. is registering up to 600,000 shares of its common stock for resale by Oaktree Fund Administration, LLC and affiliated selling stockholders. These shares are issuable upon exercise of warrants granted under a credit agreement amendment.
The selling stockholders may sell the shares over time on Nasdaq or in private transactions, using various methods described in the plan of distribution. Fortress will pay the registration costs but will not receive any proceeds from the resale of these shares. Its common stock trades on the Nasdaq Capital Market under the symbol FBIO, and 31,037,937 shares were outstanding as of December 11, 2025.
Fortress Biotech, Inc. is registering up to 600,000 shares of common stock for potential resale by Oaktree-affiliated selling stockholders. These shares are issuable upon exercise of warrants granted under a December 12, 2025 amendment to Fortress’s senior credit agreement, with an exercise price of $2.62 per share and an expiration date of July 25, 2031. The warrants became immediately exercisable and include anti-dilution adjustments and an option for net exercise without cash payment.
Fortress’s common stock trades on the Nasdaq Capital Market under the symbol FBIO, and the last reported sale price on December 11, 2025 was $2.94 per share. There were 31,037,937 shares outstanding as of that date, which would rise to 31,637,937 shares if all 600,000 warrant shares were issued. Fortress will not receive any proceeds from the resale of these shares but will cover registration expenses, while investors are referred to the company’s incorporated risk factor disclosures for a detailed discussion of risks.
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
The amendment moves the loan’s maturity from
Journey Medical Corporation, a controlled subsidiary, is now subject to higher minimum product net sales covenants, rising from
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) filed its Q3 2025 10‑Q, showing higher sales and a swing to quarterly profitability aided by non-operating gains. Net revenue was
Year to date, net revenue reached
Total liabilities fell to
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.
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