Dotinurad

Urica Therapeutics Announces Topline Data from the Phase 1 Clinical Trial Evaluating Dotinurad in Healthy Volunteers in the United States

Retrieved on: 
Thursday, June 29, 2023
Pharmacodynamics, SUA, PK, Fortress Biotech, Gout, Dotinurad, Pharmacokinetics, Patient, Therapy, Safety, Pharmaceutical industry, Hyperuricemia

MIAMI, June 29, 2023 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company focused on the development and commercialization of pharmaceutical products to treat gout and other conditions associated with hyperuricemia, today announced topline data from the Phase 1 clinical trial evaluating dotinurad in healthy volunteers in the United States (“U.S.”).

Key Points: 
  • The randomized, placebo-controlled Phase 1 clinical trial evaluated the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of multiple doses of dotinurad in U.S. healthy subjects.
  • Dotinurad was shown to be safe and well tolerated with no severe adverse events observed at any dose level.
  • Pharmacodynamic data from the Phase 1 trial were also comparable to the Japanese data where over 1,000 subjects were exposed to dotinurad, including rapid and significant serum uric acid (“sUA”) reduction.
  • We are initiating a Phase 1b clinical trial in gout patients in the U.S. this summer and expect to begin pivotal clinical trials in 2024.”

Fortress Biotech Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, May 15, 2023
CLL, Fortress Biotech, Checkpoint, Mustang Bio, Gout, Waldenström macroglobulinemia, Dotinurad, Radiation, Arm, Triplex, Fortification, Cytomegalovirus, Chronic lymphocytic leukemia, Follicular lymphoma, Biologics license application, Fred Hutchinson Cancer Research Center, ICML, Menkes disease, CKPT, New Drug Application, Clinical trial, Lymphoma, NDA, Prescription Drug User Fee Act, Prescription, Urica, WM, CAR, Waldenström, International Conference on Afghanistan, London (2010), Patient, Risk, Hyperuricemia, PD-1, FDA, Death, BLA, Conference, Rosacea, Safety, Disease, Pharmaceutical industry, Mastic (plant resin), PDUFA

MIAMI, May 15, 2023 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2023.

Key Points: 
  • In March 2023, the FDA accepted the BLA filing for cosibelimab and set a PDUFA goal date of January 3, 2024.
  • Journey Medical’s total product net revenues were $12.2 million for the first quarter of 2023, compared to first quarter 2022 total product net revenues of $20.8 million.
  • On a non-GAAP basis, Fortress research and development expenses were $2.3 million for the first quarter of 2023, compared to $2.8 million for first quarter of 2022.
  • On a non-GAAP basis, Fortress selling, general and administrative expenses were $7.0 million, for the first quarter of 2023, compared to $6.2 million for the first quarter of 2022.

Fortress Biotech Reports Record 2022 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 30, 2023
Rosacea, Fortress Biotech, Waldenström macroglobulinemia, Fortification, CD19, MACR, Chronic lymphocytic leukemia, Stanford University, Fred Hutchinson Cancer Research Center, CKPT, Prescription, Chemistry, Dermatology, Acquisition, Patient, Division, Carcinoma, BLA, Disease, CLL, Gout, FACP, Urica, B-cell lymphoma, IGA, Cytokine release syndrome, PDUFA, Growth, PD-1, FDA, Death, Biologics license application, Dotinurad, Safety, CAR, Hyperuricemia, CR, Mustang Bio, Therapy, ORR, Checkpoint, Fuji, Radiation, Follicular lymphoma, Menkes disease, Clinical trial, NDA, WM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Mustang, Food, Pharmaceutical industry, Cryptocurrency, Mastic (plant resin)

Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year.

Key Points: 
  • Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year.
  • In June 2022, we announced that the topline results of Checkpoint’s pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology Annual Meeting.
  • Also in June 2022, we announced positive interim results from Checkpoint’s pivotal trial of cosibelimab in locally advanced cSCC.
  • In July 2022, we announced that David Jin, who has served as Vice President of Corporate Development since May 2020, was also appointed as Chief Financial Officer effective August 16, 2022.