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Fortress Biotech and Subsidiary Urica Therapeutics Announce Crystalys Therapeutics’ $205 Million Series A Financing

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Fortress Biotech (NASDAQ:FBIO) and its subsidiary Urica Therapeutics announced that Crystalys Therapeutics secured a $205 million Series A financing to advance global Phase 3 clinical trials for dotinurad, a next-generation URAT1 inhibitor for gout treatment.

Urica, which sold dotinurad to Crystalys in 2024, maintains an equity stake in Crystalys and will receive a 3% royalty on future dotinurad net sales. The drug has already received approval in Japan, China, Philippines, and Thailand. The financing round was co-led by Novo Holdings, SR One, and Catalys Pacific, with participation from multiple prominent investors.

Additionally, Fortress highlighted its recent achievement of selling subsidiary Checkpoint Therapeutics to Sun Pharma, receiving $28 million upfront plus potential CVR payments and royalties on UNLOXCYT™ sales.

Fortress Biotech (NASDAQ:FBIO) e la sua filiale Urica Therapeutics annunciano che Crystalys Therapeutics ha ottenuto una finanza di Series A da 205 milioni di dollari per avanzare i trial globali di Fase 3 di dotinurad, un inibitore URAT1 di nuova generazione per il trattamento della gotta. Urica, che ha venduto dotinurad a Crystalys nel 2024, mantiene una partecipazione azionaria in Crystalys e riceverà una royalty del 3% sulle future vendite nette di dotinurad. Il farmaco ha già ottenuto l'approvazione in Giappone, Cina, Filippine e Thailandia. Il round di finanziamento è stato co-guidato da Novo Holdings, SR One e Catalys Pacific, con la partecipazione di investitori prominenti. Inoltre Fortress ha evidenziato il recente risultato di aver venduto la filiale Checkpoint Therapeutics a Sun Pharma, ricevendo 28 milioni di dollari upfront più potenziali pagamenti CVR e royalties sulle vendite di UNLOXCYT™.

Fortress Biotech (NASDAQ:FBIO) y su filial Urica Therapeutics anunciaron que Crystalys Therapeutics obtuvo una financiación de Serie A de 205 millones de dólares para impulsar ensayos clínicos globales de Fase 3 de dotinurad, un inhibidor URAT1 de próxima generación para el tratamiento de la gota. Urica, que vendió dotinurad a Crystalys en 2024, mantiene una participación accionaria en Crystalys y recibirá una regalía del 3% sobre las futuras ventas netas de dotinurad. El fármaco ya ha obtenido aprobación en Japón, China, Filipinas y Tailandia. La ronda de financiación fue co-dirigida por Novo Holdings, SR One y Catalys Pacific, con la participación de varios inversores destacados. Además, Fortress destacó su reciente logro de vender la filial Checkpoint Therapeutics a Sun Pharma, recibiendo 28 millones de dólares por adelantado y posibles pagos CVR y regalías sobre las ventas de UNLOXCYT™.

Fortress Biotech (NASDAQ:FBIO)와 그 자회사 Urica Therapeutics는 Crystalys Therapeutics가 2억 5천만 달러의 시리즈 A 펀딩을 확보했다고 발표했습니다. 이는 도티누라드(dotinurad)의 글로벌 3상 임상시험을 추진하기 위한 것이며, 통풍 치료를 위한 차세대 URAT1 억제제입니다. 2024년 Crystalys에 dotinurad를 매각한 Urica는 Crystalys의 지분을 보유하고 있으며, 향후 dotinurad의 순매출에 대해 3%의 로열티를 받습니다. 이 약은 이미 일본, 중국, 필리핀, 태국에서 승인받았습니다. 이번 펀딩 라운드는 Novo Holdings, SR One, Catalys Pacific가 공동 주도했으며 다수의 저명한 투자자들이 참여했습니다. 또한 Fortress는 자회사 Checkpoint Therapeutics를 Sun Pharma에 매각한 최근 성과를 강조하며 선지급 2,800만 달러와 향후 CVR 지급 및 UNLOXCYT™ 매출에 대한 로열티 가능성을 받게 되었다고 밝혔습니다.

Fortress Biotech (NASDAQ:FBIO) et sa filiale Urica Therapeutics ont annoncé que Crystalys Therapeutics a obtenu un financement de Series A de 205 millions de dollars pour faire progresser les essais cliniques mondiaux de Phase 3 de dotinurad, un inhibiteur URAT1 de nouvelle génération pour le traitement de la goutte. Urica, qui a vendu dotinurad à Crystalys en 2024, détient une participation dans Crystalys et recevra une royalty de 3 % sur les futures ventes nettes de dotinurad. Le médicament a déjà obtenu une approbation au Japon, en Chine, aux Philippines et en Thaïlande. La levée a été pilotée conjointement par Novo Holdings, SR One et Catalys Pacific, avec la participation de plusieurs investisseurs de premier plan. De plus, Fortress a souligné son récent fait d’armes consistant à vendre sa filiale Checkpoint Therapeutics à Sun Pharma, recevant 28 millions de dollars d’avance et des paiements CVR potentiels ainsi que des royalties sur les ventes de UNLOXCYT™.

Fortress Biotech (NASDAQ:FBIO) und seine Tochter Urica Therapeutics gaben bekannt, dass Crystalys Therapeutics eine 205 Mio. USD Series-A-Finanzierung gesichert hat, um globale Phase-3-Klinikversuche für Dotinurad voranzutreiben, einen Next-Generation URAT1-Inhibitor zur Behandlung von Gicht. Urica, das Dotinurad 2024 an Crystalys verkauft hat, hält eine Beteiligung an Crystalys und erhält eine 3%-Lizenzroyalty auf zukünftige Dotinurad-Nettoerlöse. Das Medikament hat bereits in Japan, China, den Philippinen und Thailand eine Zulassung erhalten. Die Finanzierungsrunde wurde von Novo Holdings, SR One und Catalys Pacific gemeinsam geleitet, mit Beteiligung mehrerer namhafter Investoren. Außerdem hob Fortress heraus, dass es Checkpoint Therapeutics an Sun Pharma verkauft hat, und erhält 28 Millionen USD upfront plus potenzielle CVR-Zahlungen und Lizenzgebühren auf UNLOXCYT™-Verkäufe.

Fortress Biotech (NASDAQ:FBIO) وذراعها Urica Therapeutics أعلنوا أن Crystalys Therapeutics أمنت تمويل سلسلة أ بقيمة 205 ملايين دولار لدفع التجارب السريرية العالمية من المرحلة الثالثة لـ dotinurad، وهو مثبّط URAT1 من الجيل التالي لعلاج النقرس. تعي Urica، التي بعتت dotinurad إلى Crystalys في 2024، حصة أسهم في Crystalys وستتلقى حقوق ملكية نسبتها 3% من صافي مبيعات dotinurad المستقبلية. الدواء قد حصل بالفعل على الموافقة في اليابان والصين والفلبين وتايلاند. جولة التمويل قادها بشكل مشترك Novo Holdings وSR One وCatalys Pacific، وبمشاركة من عدة مستثمرين بارزين. بالإضافة إلى ذلك، أبرزت Fortress إنجازها الأخير ببيع شركة Checkpoint Therapeutics لشركة Sun Pharma، وتلقيها 28 مليون دولار مقدماً بالإضافة إلى مدفوعات CVR محتملة وحقوق ملكية على مبيعات UNLOXCYT™.

Fortress Biotech(NASDAQ:FBIO)及其子公司 Urica Therapeutics 宣布 Crystalys Therapeutics 已获得 2.05亿美元的 A 轮融资,以推动 dotinurad 的全球 III 期临床试验,dotinurad 是用于痛风治疗的下一代 URAT1 抑制剂。Urica 在 2024 年将 dotinurad 出售给 Crystalys,仍持有 Crystalys 的股权,并将获得未来 dotinurad 净销售额的 3% 的特许权使用费。该药物已在日本、中国、菲律宾和泰国获得批准。此次融资由 Novo Holdings、SR One 与 Catalys Pacific 共同牵头,吸引多位知名投资者参与。此外,Fortress 强调其最近的成就,即将子公司 Checkpoint Therapeutics 出售给 Sun Pharma,获得 2800 万美元的前期款,并可能获得 CVR 支付及 UNLOXCYT™ 销售的特许权使用费。

Positive
  • None.
Negative
  • Minority equity position in Crystalys indicates limited control over drug development
  • Phase 3 trials still pending in US and Europe, indicating significant time to potential commercialization

Insights

FBIO's Urica subsidiary stands to benefit from Crystalys' $205M financing through equity stake and 3% future royalties on dotinurad.

This $205 million Series A financing for Crystalys Therapeutics represents a significant validation of dotinurad's market potential. The investment, co-led by prestigious firms Novo Holdings, SR One, and Catalys Pacific, provides substantial runway for Crystalys to complete global Phase 3 trials for this next-generation URAT1 inhibitor targeting gout.

The transaction structure is particularly advantageous for Fortress Biotech. Through subsidiary Urica Therapeutics, FBIO maintains both an equity position in Crystalys and a 3% royalty on future dotinurad sales. This dual-benefit arrangement creates meaningful upside exposure without the direct clinical development costs and risks, effectively transferring late-stage development expenses to Crystalys while preserving significant economic interest.

Dotinurad's profile appears compelling - it's already approved in Japan, China, Philippines, and Thailand, demonstrating regulatory validation and a de-risked safety profile. The investor syndicate's composition, featuring specialists in biopharmaceutical investing, further validates the commercial opportunity.

This deal aligns with Fortress's business model of developing assets through subsidiaries then monetizing them, similar to their recent Checkpoint Therapeutics sale to Sun Pharma that delivered $28 million upfront plus potential additional returns. The transaction effectively balances near-term value capture through the equity stake with long-term revenue potential through the royalty structure, potentially creating sustainable value for FBIO shareholders.

Dotinurad is a next-generation URAT1 inhibitor in two Phase 3 clinical trials with potential for best-in-class safety and efficacy

Urica sold dotinurad to Crystalys Therapeutics in 2024 in exchange for equity and a 3% royalty on future net sales of dotinurad

MIAMI, Oct. 01, 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, closed a $205 million Series A financing to support the advancement of global Phase 3 clinical studies evaluating dotinurad for the treatment of gout. The financing round was co-led by Novo Holdings, SR One and Catalys Pacific with participation from a broad syndicate of investors including Perceptive Xontogeny Venture Funds, Lightstone Ventures, AN Venture Partners, funds managed by abrdn Inc., KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners and Prebys Ventures Fund.

Crystalys brings together a world-class team with a proven record in gout drug development and deep regulatory success with URAT1 inhibitors. Dotinurad is a next-generation URAT1 inhibitor with potential best-in-class safety and efficacy for the treatment of gout and has demonstrated robust efficacy and a well-defined safety profile across multiple clinical studies in Asia, supporting its approval in Japan, China, Philippines, and Thailand.

Lindsay A. Rosenwald, M.D., Fortress’ Executive Chairman, President and Chief Executive Officer, said, “We are very pleased that our transaction with Crystalys could potentially expedite the development of dotinurad in the United States and Europe for millions of people suffering from gout, while simultaneously adding value to Fortress and subsidiary company, Urica, through our equity stake in Crystalys and future royalties from dotinurad once commercialized. This significant financing enables the advancement of global pivotal trials which could expeditiously lead to regulatory approval and commercialization of dotinurad in the United States and Europe.”

Dr. Rosenwald continued, “In addition to this transaction, Fortress has achieved several key milestones this year including the acquisition of our subsidiary Checkpoint Therapeutics by Sun Pharma, which was a notable validation of our business model, delivering approximately $28 million upfront, plus the potential for an additional contingent value right (CVR) payment and ongoing royalties on future sales of UNLOXCYT™ (cosibelimab-ipdl). Our goal is to continue to realize value from our extensive portfolio of commercial and clinical-stage assets, while also focusing on new business development opportunities.”

Through the sale of dotinurad to Crystalys in 2024, Urica owns a minority equity position in Crystalys and holds the right to appoint a board member to the Board of Directors of Crystalys. In addition, Urica is eligible to receive a 3% royalty on future net sales of dotinurad. Urica is a majority-owned and controlled subsidiary of Fortress.

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.

Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Company Contact:
Jaclyn Jaffe
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com

Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com  


FAQ

What is the size of Crystalys Therapeutics' Series A financing announced by Fortress Biotech (NASDAQ:FBIO)?

Crystalys Therapeutics secured a $205 million Series A financing to support global Phase 3 clinical studies of dotinurad for gout treatment.

What royalty will Urica receive from Crystalys for dotinurad sales?

Urica will receive a 3% royalty on future net sales of dotinurad.

In which countries has dotinurad already received approval?

Dotinurad has already received approval in Japan, China, Philippines, and Thailand.

How much did Fortress Biotech receive from the Checkpoint Therapeutics sale to Sun Pharma?

Fortress received $28 million upfront, plus potential additional CVR payments and ongoing royalties on future UNLOXCYT™ sales.

What is dotinurad and what is it used for?

Dotinurad is a next-generation URAT1 inhibitor being developed for the treatment of gout, with potential for best-in-class safety and efficacy.
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