08:10 AM EDT, 04/30/2025 (MT Newswires) -- XORTX Therapeutics ( XRTX ) , up 7.2% in U.S. pre-market trading on Wednesday, said the U.S. Food and Drug Administration (FDA) has clarified key steps for a new drug application (NDA) for its formulation of oxypurinol for the treatment of gout.

The Type B meeting with the FDA included a review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence to support Xortx's program for the treatment of gout. Xortx believes the gout NDA may be filed in the first half of next year.

"The clarity gained during this review of supporting data with the FDA will permit the further advancement of the XRx-026 program and will facilitate the timely completion of key steps necessary for filing the NDA," Chief Executive Allen Davidoff said.

The company's shares were last seen up US$0.07, to US$1.10, in New York trading.