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Investing.com -- Fortress Biotech Inc (NASDAQ:FBIO) stock gained 3.3% Tuesday after the company announced its subsidiary’s gout treatment entered Phase 3 clinical trials.
Urica Therapeutics, a majority-owned subsidiary of Fortress, reported that Crystalys Therapeutics has dosed the first patients in two global Phase 3 trials evaluating dotinurad, a once-daily oral URAT1 inhibitor for gout treatment. Urica maintains an equity position in Crystalys.
The trials, named RUBY and TOPAZ, will evaluate dotinurad’s safety and efficacy compared to allopurinol in adults with hyperuricemia associated with gout and tophaceous gout, respectively.
"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," said Lindsay A. Rosenwald, Fortress’ Executive Chairman, President and CEO.
Through its sale of dotinurad to Crystalys in 2024, Urica now owns a minority equity stake in Crystalys and is eligible to receive a 3% royalty on future net sales of the treatment.
Rosenwald highlighted this milestone as part of Fortress Biotech’s recent momentum, which includes two FDA approvals (Emrosi and UNLOXCYT) and the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma for approximately $355 million upfront and a potential $60 million contingent value right.
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