XORTX Therapeutics Receives Response From FDA Regarding XORLO's NDA For Gout Treatment

(RTTNews) - XORTX Therapeutics Inc. (XRTX), Wednesday announced that it has received responses from the US Food and Drug Administration regarding new drug application process for XORLO, a proprietary formulation of oxypurinol to treat individuals suffering from gout.

During the Type B meeting, the agency reviewed chemistry, manufacturing, pharmacology, toxicology and clinical evidence related to the company's XRx-026 program.

Upon receiving FDA's response, the company will now proceed to finalize meeting minutes with the agency, prepare and file an Investigative New Drug application for the XRx-026 program, characterize pharmacokinetics of XORLO, manufacture and validate commercial drug supplies, and prepare and file a NDA.

The company expects to file NDA in the first half of 2026.

In the pre-market hours, XORTX's stock is trading at $1.01, down 1.46 percent on the Nasdaq.