Fortress Biotech, INC 8-K filings

Fortress Biotech announced first quarter 2026 financial results, highlighted by FDA approval of ZYCUBO and a $205 million PRV sale, leading to significant net income.

Fortress Biotech announced its full-year 2025 financial results and corporate highlights, including FDA approvals, significant asset monetizations, and advancements in its clinical pipeline.

Fortress Biotech said majority-owned Cyprium closed the $205 million sale of its FDA Priority Review Voucher, redeemed its 9.375% preferred stock, and Fortress expects at least $100 million in aggregate proceeds subject to obligations.

Fortress Biotech's majority-owned subsidiary, Cyprium Therapeutics, entered an agreement to sell a Rare Pediatric Disease Priority Review Voucher for $205 million in cash, leading to significant loan covenant amendments.

Fortress Biotech and its subsidiary Cyprium Therapeutics announced FDA approval for ZYCUBO, the first and only treatment for Menkes disease, securing a Rare Pediatric Disease Priority Review Voucher.

Fortress Biotech amended its credit agreement, extending the loan maturity to June 2028 and issuing warrants for 600,000 common shares to lenders.

Fortress Biotech's majority-owned Cyprium Therapeutics announced the FDA accepted the resubmission of the New Drug Application for CUTX-101, setting a PDUFA target action date of January 14, 2026.

Fortress Biotech's majority-owned subsidiary, Cyprium Therapeutics, announced the resubmission of the New Drug Application for CUTX-101 to the FDA for Menkes disease.

Fortress Biotech reports a 20.5% increase in Q3 2025 net revenue to $17.6 million, achieving a net income of $3.7 million, driven by strategic divestitures and product launches.

Fortress Biotech and Cyprium Therapeutics announced the FDA issued a Complete Response Letter for CUTX-101 due to cGMP deficiencies at the manufacturing facility, not efficacy or safety.

Fortress Biotech announced significantly improved second-quarter 2025 financial results, driven by the strategic acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma.

Fortress Biotech's potential to receive up to $125 million in milestones is jeopardized after AstraZeneca announced its AL amyloidosis drug, anselamimab, failed to meet its primary endpoint in a Phase III clinical trial.

Fortress Biotech, Inc. announced the successful passage of all five proposals at its 2025 Annual Meeting, including the election of seven directors, ratification of KPMG LLP, approval of executive compensation, adoption of a three-year Say-on-Pay frequency, and officer exculpation.

Fortress Biotech, Inc. announced the completion of the sale of its subsidiary, Checkpoint Therapeutics, Inc., to Sun Pharmaceutical Industries, Inc., receiving an initial $28 million in cash and eligibility for significant future payments.

Fortress Biotech announces its Q1 2025 financial results, highlighting the upcoming acquisition of Checkpoint Therapeutics by Sun Pharma and the commercial launch of Emrosi.

Lucy Lu, M.D., resigned from Fortress Biotech's Board of Directors to accept the role of Chief Strategy Officer, effective April 21, 2025.

Fortress Biotech reports its 2024 financial results, highlighting FDA approvals for Emrosi and UNLOXCYT, the accepted New Drug Application for CUTX-101, and the acquisition of Checkpoint Therapeutics by Sun Pharma.

Sun Pharmaceutical Industries will acquire Checkpoint Therapeutics for $4.10 per share plus a contingent value right (CVR) of up to $0.70 per share, valuing the deal at approximately $490 million.

The FDA has extended the target action date for Cyprium Therapeutics' CUTX-101 New Drug Application to September 30, 2025.

Cyprium Therapeutics, a subsidiary of Fortress Biotech, has received priority review from the FDA for its drug CUTX-101, with a target action date set for June 30, 2025.

Checkpoint Therapeutics, a subsidiary of Fortress Biotech, has received FDA approval for UNLOXCYT (cosibelimab-ipdl) for the treatment of certain adults with advanced cutaneous squamous cell carcinoma.

Fortress Biotech reports its third quarter 2024 financial results, highlighted by the FDA approval of Emrosi for rosacea and progress in its pipeline.

Journey Medical, a subsidiary of Fortress Biotech, has secured FDA approval for Emrosi, a new treatment for rosacea in adults.

Fortress Biotech has successfully raised approximately $8 million through a registered direct offering and concurrent private placements.

Fortress Biotech reported a 15% increase in product revenue compared to the previous quarter and provided updates on key regulatory milestones for its drug candidates.

Fortress Biotech has entered into a new $35 million loan agreement with Oaktree, replacing its previous $50 million loan and extending its debt maturity to 2027.

Fortress Biotech's subsidiary, Urica Therapeutics, sold its gout drug candidate, dotinurad, to Crystalys Therapeutics in exchange for equity, a royalty, and potential reimbursements.

Fortress Biotech has announced a temporary halt to its monthly dividend payments on its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock to preserve cash ahead of potential regulatory approvals.

Fortress Biotech issued 2,028,345 shares of common stock to former holders of Urica Therapeutics preferred stock, fulfilling obligations under a prior agreement.

Fortress Biotech's board of directors has adopted amended bylaws that change the voting requirements for director elections and designate Delaware as the exclusive forum for legal disputes.