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.
FDA feedback defines remaining steps for a 505(b)(2) NDA
A Type B meeting with the US Food and Drug Administration clarified the key remaining steps for a new drug application for XRx-026 under the Section 505(b)(2) pathway. XORTX is now preparing an investigational new drug application. It will include new pharmacology, toxicology, chemistry and manufacturing data and an updated clinical development plan.
The plan proposes a two-part bridging study, XRx-OXY-102. Part 1 will characterize the steady-state pharmacokinetics of XORLO, the company's commercial oxypurinol tablet. Part 2 will test the therapeutic equivalence of XORLO against allopurinol in gout patients. The data would support the NDA submission, and a commercial drug supply is also required. Chemistry and manufacturing work will run in parallel with the clinical activities.
XRx-026 targets allopurinol-intolerant patients in a $700 million market
XORTX is developing XRx-026 for gout patients who cannot tolerate allopurinol. It cites a US$700 million annual market opportunity, based on inflation-adjusted peak sales of febuxostat. The company says it will advance the drug to marketing approval pending favorable study results and further FDA discussions.
Kidney disease program XRx-008 depends on a Phase 3 trial
For XRx-008, its candidate for autosomal dominant polycystic kidney disease (ADPKD), XORTX plans to submit an NDA requesting Accelerated Approval review. That step is subject to FDA discussions and successful completion of a Phase 3 registration trial. The company believes this class of drug could set a new standard of care for ADPKD.
XORTX intends to commercialize XRx-026 and XRx-008, if approved, independently and through opportunistic third-party collaborations. It also plans to develop additional xanthine oxidase inhibitor and uric acid-lowering formulations. It may add acquisitions or in-licensing deals in nephrology and diabetes.
Grasso brings investment banking and family office background
Grasso has served as a XORTX director since March 24, 2026. He is an Investment Manager at a family office, where he sources and evaluates direct and co-investments. Earlier roles include Finance Associate at Zions Capital Markets (November 2023 to March 2025), Investment Banking Associate at Paulson Investment Company (February 2022 to November 2023) and Analyst at Goldman Sachs (August 2021 to February 2022). He holds an MS in Finance and a BS in Business Administration from the Leeds School of Business at the University of Colorado Boulder.
The company lists its need for additional capital and its ability to retain newly appointed officers among the risks to its plans.