Fortress Biotech initiates NCI-funded Phase 2 trial of Triplex vaccine, targeting CMV infection prevention in stem cell transplant patients with promising immunity transfer approach.

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Click to view the official SEC document.

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Revenue reached $63.3M and cash stood at $79.4M after a year that also added a 2.5% UNLOXCYT royalty stream. Fortress cut annual net loss sharply.

Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the closing of the sale of Cyprium’s Rare Pediatric Disease Priority Review Voucher (“PRV”) for gross proceeds of

Fortress Biotech (NASDAQ: FBIO) reported Q3 2025 total net revenue of $17.6M, a 20.5% increase versus Q3 2024, driven largely by Journey Medical dermatology sales. Journey Medical net product revenue was $17.0M in the quarter vs. $14.6M a year earlier. Fortress reported consolidated net income of $3.7M ($0.13 basic, $0.11 diluted) versus a loss of $(15.0)M in Q3 2024. Consolidated cash totaled $86.2M as of Sept 30, 2025, up $28.9M year-to-date. Corporate updates include Sun Pharma's acquisition of Checkpoint (Fortress received ~$28M upfront plus potential CVR and a 2.5% royalty), dotinurad entering two Phase 3 trials, and an FDA CRL for CUTX-101 citing manufacturing (cGMP) observations with a planned resubmission.

Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the

Fortress Biotech (NASDAQ:FBIO) reported significant Q2 2025 milestones and financial results. The company's subsidiary Checkpoint Therapeutics was acquired by Sun Pharma, generating ~$28 million upfront with potential for an additional $4.8 million CVR payment and 2.5% royalties on UNLOXCYT™ sales.Key highlights include: FDA acceptance of CUTX-101's NDA with PDUFA date of September 30, 2025, commercial launch of Emrosi™ for rosacea treatment with expanded payer coverage reaching 65% of U.S. commercial lives, and consolidated net revenue of $16.4 million in Q2 2025. The company reported net income of $13.4 million ($0.50 per share basic).Cash position strengthened to $74.4 million as of June 30, 2025, up from $57.3 million at end of 2024. Journey Medical's product revenues reached $15.0 million in Q2 2025.

Q1 results reveal $91.3M cash position, Checkpoint acquisition by Sun Pharma, FDA priority review for Menkes disease drug, and successful Emrosi launch. Get details.

Fortress lands FDA approvals for Emrosi and UNLOXCYT, secures $28M Sun Pharma deal, while streamlining operations. See full analysis of strategic transformation.

Fortress Biotech leverages Partex's AI platform to revolutionize drug asset evaluation, accelerating development pipeline while two approved drugs generate revenue.

FDA accepts NDA for CUTX-101 with Priority Review, showing 80% reduction in mortality for Menkes disease. Could become first approved treatment with June 2025 PDUFA date.