Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics' Global Phase 3 Trials of Dotinurad for the Treatment of Gout

MIAMI, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. ("Urica" or the "Company"), a Fortress Biotech, Inc. (NASDAQ:FBIO) ("Fortress") subsidiary, today announced that Crystalys Therapeutics, Inc. ("Crystalys"), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.

These Phase 3 clinical studies are designed to evaluate the safety and efficacy of dotinurad compared to an active control arm (physician-determined stable dose of allopurinol) in adults with hyperuricemia associated with gout (RUBY) and adults with tophaceous gout (TOPAZ).

Lindsay A. Rosenwald, M.D., Fortress' Executive Chairman, President and Chief Executive Officer, said, "Initiating the Phase 3 clinical trials represents a significant step forward in potentially expediting the development and regulatory approval of dotinurad in the United States and Europe for millions of people suffering from gout. We look forward to seeing the Crystalys team continue to execute on the clinical development program and achieve significant value inflection in the future."

Dr. Rosenwald continued, "The initiation of these pivotal clinical trials marks another important milestone for Fortress, building on the significant momentum achieved over the past year. This includes two U.S. FDA approvals — Emrosi™ and UNLOXCYT™ (cosibelimab-ipdl) — and the acquisition of our subsidiary, Checkpoint Therapeutics, by Sun Pharma, for an aggregate upfront payment totaling ~$355 million and ~$60 million payable in a contingent value right (CVR), of which Fortress received approximately $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 to Fortress. We remain focused on unlocking value across our diversified portfolio of commercial and clinical-stage assets, while pursuing strategic business development opportunities to drive future growth."

Through the sale of dotinurad to Crystalys in 2024, Urica owns a minority equity position in Crystalys and is eligible to receive a 3% royalty on future net sales of dotinurad. Urica is a majority-owned and controlled subsidiary of Fortress.

About the RUBY Study

The RUBY study (NCT07089875) is a Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of dotinurad in approximately 500 patients with hyperuricemia associated with gout. Study participants will be given dotinurad orally once a day for up to 64 weeks.

About the TOPAZ Study

The TOPAZ study (NCT07089888) is a Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of dotinurad in approximately 250 patients with tophaceous gout. Study participants will be given dotinurad orally once a day for up to 76 weeks.

About Gout

Gout is the most common form of inflammatory arthritis. It is a condition that is very debilitating for patients and characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints. This disease arises from excess uric acid in the body, known as ‘hyperuricemia,' which causes buildup of uric acid crystals and inflammation, leading to tophaceous gout in people with chronic or undertreated disease. Despite available therapies that aim to reduce uric acid levels below the target 6 mg/dL, a major treatment gap remains between first-line xanthine oxidase inhibitors (XOIs) and last-line uricase therapy. Currently, no suitable second-line options exist in the U.S. or E.U., leaving a critical unmet need for patients who fail to respond to first-line treatments.

About Fortress Biotech 

Fortress Biotech, Inc. ("Fortress") is 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. The company has eight marketed prescription pharmaceutical products and multiple programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress' portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress' model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company's portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Nationwide Children's Hospital, Columbia University, Dana Farber Cancer Center and Sentynl Therapeutics. For more information, visit www.fortressbiotech.com.

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Fortress Biotech, Inc.

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