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. 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 $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) filed its Q3 2025 10‑Q, showing higher sales and a swing to quarterly profitability aided by non-operating gains. Net revenue was $17.6 million versus $14.6 million a year ago, while loss from operations was $6.8 million. Other income of $15.7 million drove net income of $8.8 million; income attributable to Fortress was $5.9 million and net income to common stockholders was $3.7 million (diluted EPS $0.11).
Year to date, net revenue reached $47.2 million and the company recorded a $27.1 million gain from deconsolidating Checkpoint after its sale to Sun Pharma, plus $2.6 million other income tied to Urica’s Crystalys transaction. Cash and cash equivalents were $86.2 million, up from $57.3 million at year‑end, as financing and investing inflows offset operating cash use of $53.2 million.
Total liabilities fell to $116.2 million and total stockholders’ equity improved to $65.2 million. Common shares outstanding were 31,037,937 as of November 10, 2025. The filing states Parent Entity cash of $38.6 million is sufficient for at least 12 months following the filing date.
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.
David Jin, Chief Financial Officer of Fortress Biotech, Inc. (FBIO), reported an acquisition of 2,711 common shares on 10/01/2025 under the company's Employee Stock Purchase Plan at a price of $1.309 per share. The filing states the purchase was exempt under Rule 16b-3(c) and 16b-3(d). After the transaction, Mr. Jin beneficially owns 1,248,604 shares, which the filer says include 1,230,000 shares underlying deferred restricted stock units. The Form 4 is signed and dated 10/02/2025.
Fortress Biotech, Inc. (reporting person) reported a Section 16 filing related to Mustang Bio, Inc. (MBIO). On 09/29/2025 the reporting person received 59,334 shares of Mustang Bio common stock at a reported price of $0, increasing its beneficial ownership to 258,192 shares. The filing states these shares were granted under an agreement that awards the reporting person equity equal to 2.5% of the gross proceeds of any debt or equity financing; the grant followed the issuer’s receipt of proceeds from the exercise of previously issued warrants. The Form 4 is signed by an attorney-in-fact for the reporting person on 10/01/2025.
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.