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.
Fortress Biotech, Inc. filings document a biopharmaceutical issuer with common stock and 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock listed on the Nasdaq Capital Market. Its SEC record includes Form 8-K reports on operating results, FDA approvals, priority review voucher monetization, credit agreement amendments and subsidiary capital actions.
Proxy materials describe annual meeting matters, board governance, executive compensation and equity awards. Registration statements and material-event filings add disclosure on securities offerings, capital structure, risk factors, material agreements and ownership interests in portfolio companies such as Cyprium Therapeutics and Journey Medical.
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.