Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout
Fortress Biotech (NASDAQ: FBIO) subsidiary Urica Therapeutics announced that Crystalys Therapeutics dosed first patients in two global Phase 3 trials of dotinurad (RUBY NCT07089875; TOPAZ NCT07089888) on Oct 21, 2025. The studies compare once-daily oral URAT1 inhibitor dotinurad to physician-determined stable allopurinol in adults with gout and tophaceous gout.
Urica holds a minority equity stake in Crystalys and is eligible for a 3% royalty on future dotinurad sales. Fortress highlighted recent value events, including two U.S. FDA approvals (Emrosi and UNLOXCYT) and the Checkpoint Therapeutics sale that generated approximately $28M upfront.
Fortress Biotech (NASDAQ: FBIO) la controllata Urica Therapeutics ha annunciato che Crystalys Therapeutics ha dosato i primi pazienti in due studi globali di fase 3 di dotinurad (NCT07089875 RUBY; NCT07089888 TOPAZ) il 21 ottobre 2025. Gli studi confrontano l'inibitore orale giornaliero URAT1 dotinurad con l'allopurinolo stabile determinato dal medico negli adulti con gotta e gotta tofosica.
Urica detiene una partecipazione azionaria di minoranza in Crystalys ed è idonea per una royalty del 3% sulle future vendite di dotinurad. Fortress ha evidenziato recenti eventi di valore, tra cui due approvazioni FDA USA (Emrosi e UNLOXCYT) e la vendita di Checkpoint Therapeutics che ha generato circa $28M upfront.
Fortress Biotech (NASDAQ: FBIO) la subsidiaria Urica Therapeutics anunció que Crystalys Therapeutics dosó a los primeros pacientes en dos ensayos globales de fase 3 de dotinurad (RUBY NCT07089875; TOPAZ NCT07089888) el 21 de octubre de 2025. Los estudios comparan el inhibidor oral diario URAT1 dotinurad con allopurinol estable determinado por el médico en adultos con gota y gota tofosica.
Urica mantiene una participación accionaria minoritaria en Crystalys y es elegible para una regalía del 3% sobre futuras ventas de dotinurad. Fortress destacó eventos de valor recientes, incluidas dos aprobaciones de la FDA en EE. UU. (Emrosi y UNLOXCYT) y la venta de Checkpoint Therapeutics que generó aproximadamente 28 millones de dólares como pago inicial.
Fortress Biotech (NASDAQ: FBIO) 자회사 Urica Therapeutics는 Crystalys Therapeutics가 dotinurad의 두 건의 글로벌 3상 시험에 최초로 환자를 투여했다고 발표했다. (RUBY NCT07089875; TOPAZ NCT07089888) 날짜는 2025년 10월 21일이다.
Urica는 Crystalys의 소수 지분을 보유하고 있으며 향후 dotinurad 매출에 대해 3% 로열티를 받을 자격이 있다. Fortress는 미국 FDA의 두 승인(Emrosi 및 UNLOXCYT)과 Checkpoint Therapeutics 매각으로 약 $28M 선지급이 발생한 등 최근의 가치 창출 이벤트를 강조했다.
Fortress Biotech (NASDAQ: FBIO) la filiale Urica Therapeutics a annoncé que Crystalys Therapeutics a dosé les premiers patients dans deux essais mondiaux de Phase 3 de dotinurad (RUBY NCT07089875; TOPAZ NCT07089888) le 21 octobre 2025. Les études comparent l'inhibiteur URAT1 oral quotidien dotinurad à l'allopurinol stable déterminé par le médecin chez les adultes souffrant de goutte et de goutte tophacée.
Urica détient une participation minoritaire dans Crystalys et est éligible à une royauté de 3% sur les ventes futures de dotinurad. Fortress a mis en évidence des événements de valeur récents, notamment deux approbations FDA aux États-Unis (Emrosi et UNLOXCYT) et la vente de Checkpoint Therapeutics qui a généré environ 28 M$ en paiement initial.
Fortress Biotech (NASDAQ: FBIO) Tochtergesellschaft Urica Therapeutics gab bekannt, dass Crystalys Therapeutics die ersten Patienten in zwei globalen Phase-3-Studien von dotinurad (RUBY NCT07089875; TOPAZ NCT07089888) am 21. Oktober 2025 dosierte. Die Studien vergleichen den einmal täglich eingenommenen URAT1-Inhibitor dotinurad mit dem vom Arzt bestimmten stabilen Allopurinol bei Erwachsenen mit Gicht und toföse Gicht.
Urica hält eine Minderheitsbeteiligung an Crystalys und ist berechtigt auf eine 3%-Royalty bei zukünftigen Dotinurad-Verkäufen. Fortress hob kürzlich wertsteigernde Ereignisse hervor, darunter zwei FDA-Zulassungen in den USA (Emrosi und UNLOXCYT) sowie den Verkauf von Checkpoint Therapeutics, der rund 28 Mio. USD upfront generierte.
Fortress Biotech (NASDAQ: FBIO) أعلنت شركةها الفرعية Urica Therapeutics أن Crystalys Therapeutics جرَّبت أول مرضى في تجربتين عالميتين من المرحلة الثالثة لـ dotinurad (RUBY NCT07089875؛ TOPAZ NCT07089888) في 21 أكتوبر 2025. تقارن الدراسات مثبِّط URAT1 الفموي اليومي dotinurad بالـ allopurinol المستقر الذي يحدده الطبيب للبالغين المصابين بالنقرس ونقرس التوِفُّسي.
تمتلك Urica حصة أسهم الأقلية في Crystalys وهي مؤهلة للحصول على رُوُليتي 3% من مبيعات dotinurad المستقبلية. وأبرزت Fortress أحداث قيمة حديثة، بما في ذلك موافقتان من FDA الأمريكية (Emrosi و UNLOXCYT) وبيع Checkpoint Therapeutics الذي حقق نحو $28M كدفعة مقدمة.
Fortress Biotech (NASDAQ: FBIO) 的子公司 Urica Therapeutics 宣布，Crystalys Therapeutics 已在两项全球性3期试验中给出第一批受试者，研究药物为 dotinurad（RUBY NCT07089875；TOPAZ NCT07089888），时间为 2025年10月21日。研究比较每日一次口服的 URAT1 抑制剂 dotinurad 与医生确定的稳定别嘌醇，用于成人痛风及泡病痛风患者。
Urica 在 Crystalys 持有少数股权，并有资格就未来 dotinurad 的销售获得 3% 的特许权使用费。Fortress 强调了近期的价值事件，包括两项美国 FDA 批准（Emrosi 和 UNLOXCYT）以及 Checkpoint Therapeutics 的出售，前者带来约 $2800 万美元的前期款。
- Crystalys initiated two global Phase 3 trials (RUBY, TOPAZ)
- Urica eligible for a 3% royalty on dotinurad net sales
- Fortress received approximately $28M upfront from Checkpoint sale
- Urica retains only a minority equity position in Crystalys
- Fortress received $28M of a larger $355M aggregate sale upfront
Insights
Initiation of two global Phase 3 trials for dotinurad is a material clinical progress milestone but does not yet change commercial outlook.
Crystalys began dosing first patients in two randomized, double-blind, multicenter global Phase 3 trials (RUBY and TOPAZ) testing dotinurad, an oral URAT1 inhibitor, versus physician‑determined stable doses of allopurinol in adults with hyperuricemia associated with gout and adults with tophaceous gout. Urica retains a minority equity stake in Crystalys and is contractually eligible for a
The business mechanism is straightforward: Phase 3 initiation advances regulatory path and preserves future commercial optionality for dotinurad while creating a potential royalty stream for Urica and indirect value for Fortress. The development program’s value hinges on achieving positive Phase 3 efficacy and safety outcomes and subsequent regulatory approvals; initiation alone carries scientific and regulatory risk and does not guarantee approval or revenue. Watch for enrollment milestones, predefined primary endpoint readouts, and any disclosed timelines for topline data or regulatory filings over the next 12–36 months (
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 ~
Through the sale of dotinurad to Crystalys in 2024, Urica owns a minority equity position in Crystalys and is eligible to receive a
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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FAQ
What trials did Fortress report dosing first patients in on October 21, 2025?
What is dotinurad and which condition is it being tested for by Crystalys?
What financial interest does Urica/ Fortess have in dotinurad (FBIO)?
How does the Checkpoint Therapeutics transaction affect Fortress' cash position?
Which FDA approvals did Fortress cite as recent milestones in the Oct 21, 2025 announcement?
What comparator is being used in the RUBY and TOPAZ Phase 3 trials for dotinurad?
