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.
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