07:55 AM EDT, 03/19/2025 (MT Newswires) -- XORTX Therapeutics ( XRTX ) , which is developing therapies to treat progressive kidney disease and gout, on Wednesday said it has prepared a broad Type B meeting package at the request of the Food and Drug Administration.

The package to be submitted includes a review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding XORTX's XRx-026 program for the treatment of gout. The meeting will review the XRx-026 program and its readiness for submission of a New Drug Application (NDA) to gain marketing approval for XORLO in the U.S. The FDA is expected to provide feedback by the end of April.

"Many key elements of the XRx-026 program have advanced sufficiently to warrant this robust program review with the FDA to define any additional information needed to complete this marketing approval," said Chief Executive Allen Davidoff. "We believe that the XRx-026 program provides a much needed therapeutic option for individuals with gout and that advancing with the XRx-026 program will transform XORTX to a revenue positive state."