Fortress Biotech Reports 2025 Financial Results and Recent Corporate Highlights

ZYCUBO® approved by FDA to treat Menkes disease in the United States; Fortress subsidiary Cyprium Therapeutics sold its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $205 million; Cyprium is also eligible to receive tiered royalties and up to approximately $128 million in aggregate sales milestones from Sentynl Therapeutics

Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress remains eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on net sales of UNLOXCYT™ (cosibelimab-ipdl)

MIAMI, March 31, 2026 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, today announced financial results and recent corporate highlights for the full-year ended December 31, 2025.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “2025 and early 2026 reflect disciplined execution across our portfolio, including monetizing assets, achieving key regulatory approvals and advancing high-value clinical programs. The acquisition of Checkpoint Therapeutics, Inc. (“Checkpoint”) by Sun Pharma generated meaningful upfront capital and established a long-term royalty stream from UNLOXCYT™ (cosibelimab-ipdl), highlighting the strength of our business model. The FDA approval of ZYCUBO® for Menkes disease, followed by the recent sale of the Rare Pediatric Disease Priority Review Voucher (“PRV”) for $205 million by our majority-owned subsidiary Cyprium Therapeutics, Inc. (“Cyprium”), demonstrates our continued ability to advance our portfolio toward value-generating approvals and corporate transactions. Additionally, the progression of dotinurad into Phase 3 by Crystalys Therapeutics, to which we transferred rights to dotinurad in exchange for equity in Crystalys and a 3% royalty on dotinurad sales, supported by its Series A $205 million financing, further validates our strategy of building diversified revenue streams and creating long-term shareholder value.”

Recent Corporate Highlights1:

Regulatory Updates

• ZYCUBO® Approved for Menkes Disease; Cyprium Sold PRV for $205 Million; Royalty and Milestone Participation Secured. In January 2026, the FDA approved ZYCUBO® (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric patients. A PRV was issued at approval and transferred to Cyprium under its agreement with Sentynl Therapeutics, Inc. (“Sentynl”). In March 2026, Cyprium closed the sale of the PRV for gross proceeds of $205 million. Cyprium is also eligible to receive tiered royalties on net sales of ZYCUBO® and up to approximately $128 million in aggregate sales milestones from Sentynl. ZYCUBO® was commercially launched by Sentynl subsequent to approval.
  • In connection with the sale of the PRV, Cyprium redeemed all outstanding shares of its 9.375% Perpetual Preferred Stock pursuant to the previously disclosed terms of such securities.
  • In total, Fortress expects to receive an aggregate of at least $100 million from Cyprium pursuant to potential future dividends and intercompany agreements, including amounts owed by Cyprium to Fortress through intercompany debt, interest and accrued expenses. The amount Fortress will receive is subject to change based on various considerations including, but not limited to, Cyprium’s obligation to pay 20% of the proceeds from a PRV sale to an institute of the National Institutes of Health, Cyprium’s tax obligations on the income received from the PRV sale, any future dividends that may be approved by Cyprium’s Board of Directors, and Cyprium’s outstanding and future obligations.

Monetization Updates

• Checkpoint Acquired by Sun Pharma; Fortress Establishes Long-Term Royalty Stream. In May 2025, Fortress’ subsidiary, Checkpoint, was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, “Sun Pharma”). Checkpoint was acquired for an aggregate upfront payment totaling ~$355 million and ~$60 million payable in a contingent value right (“CVR”), of which Fortress received ~$28 million upfront, with the potential for an additional CVR payment of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl). UNLOXCYT™ was approved by the FDA in December 2024 to treat metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) in patients who are not candidates for curative surgery or radiation and was commercially launched in January 2026.
• Avenue Therapeutics’ Subsidiary Baergic Acquired by Axsome. In November 2025, Avenue Therapeutics, Inc.’s (“Avenue”) subsidiary Baergic Bio, Inc. (“Baergic”) was acquired by Axsome Therapeutics (“Axsome”). Under the terms of the purchase agreement, Baergic shareholders received a $0.3 million upfront payment (less transaction expenses) and are eligible to receive milestone payments of up to $2.5 million upon the occurrence of certain development and regulatory events for the first indication for AXS-17 (formerly known as BAER-101). Avenue, a Fortress subsidiary, is eligible to receive approximately 74% of all future milestone and royalty payments under the agreement, including up to $79 million in potential sales milestones and tiered mid-to-high single-digit royalties.
• $205 Million Series A Raised by Crystalys to Advance Dotinurad Phase 3 Program. In the third quarter of 2025, Crystalys Therapeutics (“Crystalys”), in which our majority-owned and controlled subsidiary company Urica Therapeutics, Inc. (“Urica”), maintains an equity position, announced a $205 million Series A financing to support two global Phase 3 clinical studies evaluating dotinurad for gout. Urica is eligible to receive a 3% royalty on future net sales of dotinurad. Urica entered into an asset purchase agreement, royalty agreement and related agreements with Crystalys in July 2024.

Commercial Product Updates

• Journey Medical Expands Commercial Footprint of Emrosi™. At the end of March 2025, our partner company Journey Medical Corporation (“Journey Medical”), commercially launched Emrosi™ (40mg Minocycline Hydrochloride Modified-Release Capsules, consisting of 10mg immediate release and 30mg extended release pellets), also known as DFD-29, for inflammatory lesions of rosacea. Emrosi™ was approved by the FDA in November 2024 and is available by prescription at specialty pharmacy chains. Journey Medical reported net product revenues of $61.2 million for full-year 2025, compared to net product revenues of $55.1 million for the full year ended December 31, 2024.

Clinical Updates

• Dotinurad Enters Phase 3 Development. In October 2025, the first patients were dosed in Crystalys’ two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.
• Phase 3 CARES Results for Anselamimab (CAEL-101); Regulatory Submission of Prespecified Subgroup Analysis Planned. In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival (“CARES”) clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials to regulatory authorities.
• Emrosi™ Phase 3 Data Published in JAMA Dermatology and Journal of Drugs in Dermatology. In March 2025, full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 (“MVOR-1”) and Minocycline Versus Oracea® in Rosacea-2 (“MVOR-2”), evaluating Emrosi™ for the treatment of moderate-to-severe papulopustular rosacea in adults, were published in the Journal of the American Medical Association - Dermatology. The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. The full publication is available at https://jamanetwork.com/journals/jamadermatology/article-abstract/2830693. Information on such website is not a part of this release. In December 2025, results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline (commercially known as Emrosi™) on skin, gastrointestinal (“GI”) and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology. The clinical trial also assessed the safety and tolerability of the treatment. The results indicate that DFD-29 administration for 16 weeks had no detectable effects on skin, GI tract or vaginal microflora and it was well tolerated in healthy adults, supporting its use as a therapeutic option for patients with moderate-to-severe rosacea.
• Emrosi™ Phase 3 Results Presented at Scientific Meetings. In June 2025, a data analysis from the two Phase 3 multicenter clinical trials evaluating Emrosi™ for the treatment of moderate-to-severe papulopustular rosacea in adults was presented at the Society of Dermatology Physician Associates 2025 Summer Dermatology Conference. The analysis determined that differences in body weight did not affect the efficacy of Emrosi™ in the two Phase 3 trials, which supported its November 2024 FDA approval. In October 2025, efficacy data from a pooled analysis of the MVOR-1 and MVOR-2 trials were presented at the 2025 Fall Clinical Dermatology Conference and demonstrated superior efficacy in Investigator’s Global Assessment treatment success rates and inflammatory lesion counts versus both placebo and doxycycline (P