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XORTX Announces Update for Discussion with the FDA
● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● CALGARY, ...
About this update from Xortx Therapeutics, Inc.
[{"type":"text","content":"XORTX Announces Update for Discussion with the FDA\n\n\n\n\n ● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ●\n \n\n\n CALGARY, Alberta, March 19, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. (\"\n \n XORTX\n \n \" or the “\n \n Company\n \n ”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease and gout, is pleased to provide an update regarding communications with the US Food and Drug Administration (the “FDA”). At the request of the FDA a type B meeting package will be provided by the Company during the next week, and accompanying FDA communications are expected by April 26, 2025. The Company has prepared a broad Type B meeting review at the request of the FDA, including review of chemistry, manufacturing, pharmacology, toxicology and clinical evidence regarding the Company’s XRx-026 program for the treatment of gout. Drug Development of XORLO\n \n TM\n \n , the Company’s proprietary drug formulation of oxypurinol, has advanced substantially to a state where a Type B meeting and discussion with the FDA to confirm the developmental state of each element of the program is warranted. The purpose of this meeting will be to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLO\n \n TM\n \n in the US using the FDA 505(b)2 development pathway. The Company believes that a Type B meeting will facilitate a broader discussion toward market approval.\n \n\n Dr. Allen Davidoff, CEO of XORTX commented, “We look forward to FDA feedback the last week in April and advancing the XRx-026 program, thereafter. 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. 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.”\n \n\n The Company will provide further updates following communications with the FDA when additional information is available.\n \n\n\n About Hyperuri...