XORTX Targets Q4 FDA Filing for Gout Drug, Sees $700M Market
XRTX is trading near its 52-week low of $1.59 (5.7% above the low) on elevated volume (21× avg).
Summary
XORTX plans to submit an IND for its XRx-026 gout program to the FDA in Q4 2026, with a target NDA filing in about a year. The company estimates the U.S. market opportunity at $700M annually, based on prior febuxostat sales. This follows the start of GMP manufacturing for XORLO™ announced on September 10, 2026, and comes amid a going concern warning and recent board changes. The IND submission is a concrete regulatory step that could de-risk the program, but the company still needs funding to complete the planned XRX-OXY-102 trial.
At the time of this announcement, XRTX was trading at $1.68 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3M. The 52-week trading range was $1.59 to $7.05. This news item was assessed with neutral market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.