Business UpdateJun 15, 2026, 07:02 AM
XORTX Therapeutics Advances Gout Program, Appoints New Co-CEO
AI Summary
XORTX Therapeutics provided a corporate update, focusing on restructuring, re-initiating drug development, and preparing regulatory filings for its lead gout program, XRx-026. The company clarified with the FDA the remaining steps for a New Drug Application (NDA) via the 505(b)(2) pathway and is developing an Investigational New Drug (IND) application. XRx-026 targets a US $700 million per year market for allopurinol-intolerant gout patients. Additionally, Mika Grasso was appointed as co-CEO for finance and public markets, enhancing the c-suite effectiveness.
Key Highlights
- XORTX is re-initiating drug development programs and preparing regulatory filings for its lead gout program, XRx-026.
- FDA feedback clarified key steps for XRx-026 NDA submission using the Section 505(b)(2) regulatory pathway.
- The company is developing an IND application for XRx-026, including new data and a two-part clinical study.
- XRx-026 targets a US $700 million per year market for gout patients intolerant to allopurinol.
- Mika Grasso was appointed as co-CEO, responsible for finance and public markets.
- The strategic path includes IND/NDA submission for XRx-026, aiming for marketing approval within 18 months.
- Plans to submit NDA for XRx-008 (ADPKD) under Accelerated Approval after successful Phase 3 trial.
Price Impact
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