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14.01.26 - 11:36
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Fortress Biotech receives FDA approval for Zycubo to treat Menkes disease (PBR)
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Menkes disease is a rare X-linked recessive disorder caused by mutations in the ATP7A gene, resulting in impaired copper absorption and transport. Zycubo is administered subcutaneously to restore
The post Fortress Biotech receives FDA approval for Zycubo to treat Menkes disease appeared first on Pharmaceutical Business review....
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21.10.25 - 14:33
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Fortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics Global Phase 3 Trials of Dotinurad for the Treatment of Gout (GlobeNewswire EN)
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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....
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01.10.25 - 14:06
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Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101 (GlobeNewswire EN)
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MIAMI, Oct. 01, 2025 (GLOBE NEWSWIRE) -- 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 New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients....
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02.09.25 - 14:33
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Fortress Biotech to Present at the H.C. Wainwright 27th Annual Global Investment Conference (GlobeNewswire EN)
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MIAMI, Sept. 02, 2025 (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 that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference. The presentation will be available for on-demand viewing by conference attendees starting on Friday, September 5, 2025, at 7:00 a.m. ET. The Company will also attend virtual one-on-one meetings during the conference taking place September 8-11, 2025....
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