Fortress Biotech Inc (NASDAQ:FBIO) stock climbed 3.3% on Tuesday after the company revealed that a treatment developed by one of its subsidiaries had advanced into Phase 3 clinical trials for gout.
Urica Therapeutics, a majority-owned subsidiary of Fortress, announced that Crystalys Therapeutics has begun dosing patients in two global Phase 3 studies testing dotinurad, a once-daily oral URAT1 inhibitor designed to treat gout. Urica holds an equity interest in Crystalys.
The trials — named RUBY and TOPAZ — will evaluate the safety and efficacy of dotinurad against allopurinol in adults with hyperuricemia linked to 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.
Following the 2024 sale of dotinurad to Crystalys, Urica retained a minority equity position and remains eligible to receive a 3% royalty on future net sales.
Rosenwald noted that this achievement reflects Fortress Biotech’s recent string of strategic wins, including two FDA approvals — for Emrosi and UNLOXCYT — and the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharmaceutical Industries for approximately $355 million upfront plus a potential $60 million contingent value right.