XORTX Advances NDA Filing for Gout Treatment Following FDA Guidance

An update from XORTX Therapeutics Inc ( (TSE:XRTX) ) is now available.

On April 30, 2025, XORTX Therapeutics Inc. announced it received responses from the FDA regarding its new drug application (NDA) for its proprietary formulation of oxypurinol, XORLO™, for the treatment of gout. The FDA’s Type B meeting provided clarity on the steps required for NDA submission, including finalizing meeting minutes, preparing an Investigative New Drug application, characterizing pharmacokinetics, and manufacturing commercial supplies. This guidance is expected to facilitate the timely completion of the NDA filing, anticipated in the first half of 2026, which could significantly impact XORTX’s market position by addressing unmet medical needs in the gout treatment landscape.

Spark’s Take on TSE:XRTX Stock

According to Spark, TipRanks’ AI Analyst, TSE:XRTX is a Underperform.

The overall stock score for XORTX Therapeutics Inc is low, driven primarily by its poor financial performance with no revenue and consistent losses. The technical analysis indicates bearish market conditions, further weighing down the score. Valuation metrics also reflect a negative assessment as the P/E ratio is negative, with no dividends to offset the lack of earnings. The combination of these factors suggests significant challenges ahead for the company.

To see Spark’s full report on TSE:XRTX stock, click here.

More about XORTX Therapeutics Inc

XORTX Therapeutics Inc. is a pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease. The company has three clinically advanced products in development, including the XRx-026 program for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney and other organ injuries related to respiratory virus infections. XORTX aims to target aberrant purine metabolism and xanthine oxidase to decrease or inhibit uric acid production, thereby improving the quality of life for individuals with gout and other diseases.

YTD Price Performance: -7.83%

Average Trading Volume: 7,141

Technical Sentiment Signal: Buy

Current Market Cap: C$5.8M

For an in-depth examination of XRTX stock, go to TipRanks’ Stock Analysis page.