Xortx Therapeutics Inc Stock Price, News & Analysis

XORTX Therapeutics has received Orphan Drug Designation from the FDA for oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD). This designation is a significant milestone in the development of XORLO^TM, which may slow progression of kidney damage associated with ADPKD. While not an approval for patient use yet, it positions XORTX favorably for marketing approval.

The Orphan Drug Act provides benefits like seven years of exclusive marketing rights, 25% tax credits on clinical testing costs, and regulatory assistance, all essential for the drug's development. A planned FDA meeting on May 1, 2023, will further discuss phase 3 clinical trials. XORTX has demonstrated positive results in preclinical animal models, showing potential effectiveness in treating ADPKD.

XORTX Therapeutics has submitted a Type D meeting request to the FDA for its clinical program concerning XRX-OXY-301, aiming to expedite the approval process for XORLO^TM, its innovative treatment for autosomal dominant polycystic kidney disease (ADPKD). A virtual meeting is set for May 1, 2023. The revised protocol aims to gather data necessary for accelerated approval of the drug based on total kidney volume metrics. The trial will target patients with stages 2-4 ADPKD and high uric acid levels and is expected to commence in the latter half of 2023.