XORTX Appoints Mika Grasso as Co-CEO Amid 505(b)(2) NDA Push for Gout Drug XRx-026

A Type B FDA meeting has sharpened the regulatory roadmap for XORTX Therapeutics, with the Calgary-based company now building an IND package around new pharmacology, toxicology, and CMC data as it targets an NDA submission for XRx-026 via the 505(b)(2) pathway. The appointment of Mika Grasso as co-CEO, with responsibility for finance and public markets, runs in parallel with that technical push.

The IND under preparation, designated XRX-OXY-102, will support a two-part bridging clinical study. Part 1 will characterize the steady-state pharmacokinetics of XORLO, the company's commercial oxypurinol tablet formulation. Part 2 will evaluate therapeutic equivalence against allopurinol in gout patients who are intolerant to that standard of care. For CMC leads, the company has flagged that chemistry and manufacturing scale-up for both clinical and commercial supply will proceed in parallel with clinical activities, a sequencing decision that carries resource and timeline implications.

The 505(b)(2) route allows XORTX to rely in part on existing published data and FDA findings for allopurinol, but the bridging study data will need to satisfy the agency's requirements for therapeutic equivalence before an NDA can be filed. FDA feedback from the Type B meeting defined the remaining key steps, giving the program a clearer submission checklist than it held previously.

Beyond XRx-026, XORTX is advancing XRx-008 for autosomal dominant polycystic kidney disease under a separate track, with a Phase 3 registration trial and a subsequent NDA submission targeting Accelerated Approval status. The two programs together represent the company's pipeline-in-a-product strategy across gout and progressive kidney disease.

XORTX has cited a US $700 million annual market opportunity for XRx-026 in allopurinol-intolerant gout patients, though commercial projections remain contingent on study outcomes and FDA alignment at each submission stage.

The NDA filing timeline for XRx-026 will depend on IND acceptance, successful completion of XRX-OXY-102, and the adequacy of CMC packages supporting both clinical and commercial drug supply.

Source: XORTX Therapeutics Inc. via GlobeNewswire, June 15, 2026.