XORTX Therapeutics Inc. (XRTX), Wednesday announced that the company has an upcoming Type B meeting with the US Food and Drug Administration regarding its XRx-026 program for the treatment of gout.
The XRx-026 program is developing XORLO, a proprietary formulation of oxypurinol to treat individuals suffering from gout, an inflammatory arthritis.
The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application to gain marketing approval for XORLOTM in the US using the FDA 505(b)2 development pathway.
The company stated that it will submit a type B meeting package to the FDA during the next week, with FDA communications expected by April 26, 2025.
The Type B meeting review will include review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding XRx-026 program.
Currently, XORTX's stock is moving up 5.78 percent, to $1.005 on the Nasdaq.
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