XORTX Therapeutics

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX | TSXV: XRTX) has appointed Mika Grasso, 28, as co-CEO responsible for finance and public markets, and says it aims to advance its lead gout program, XRx-026, toward marketing approval over the next 18 months.

The company says the appointment follows a recent financing and growing investor interest. It is now restructuring its corporate and issuer status, re-initiating drug development programs and preparing regulatory filings for XRx-026. Risk disclosures in the release also refer to a voluntary delisting that may not be completed on the anticipated timeline, or at all.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to submit an Investigational New Drug application to the U.S. FDA in the fourth quarter of 2026 for its XRx-026 gout program, and estimates the program addresses a US$700M annual market opportunity.

XORTX targets an NDA filing in about one year, contingent on funding

The IND describes the company's clinical development plan for XORLOTM, its proprietary oxypurinol formulation, and its intention to file a New Drug Application after completing the two-part XRX-OXY-102 clinical trial. The trial is designed to characterize the pharmacokinetics and efficacy information the FDA needs to evaluate a future NDA.

Calgary – October 12, 2026 -- XORTX Therapeutics (NASDAQ: XRTX) plans to run the first part of its two-part XRX-OXY-102 gout study in Canada, a move it expects to speed delivery of the clinical data needed for a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

XORTX prepares Health Canada filing in parallel with FDA track

The company has outlined an anticipated Clinical Trial Application (CTA) to Health Canada for its XRx-026 gout program. The study evaluates XORLO, XORTX's proprietary formulation of oxypurinol, a xanthine oxidase inhibitor. Drug development teams have been preparing the CTA in parallel with the planned FDA NDA submission.