XORTX appointed Mika Grasso as co-CEO for finance and markets following recent financing to accelerate restructuring and drug development. The company is preparing an IND and two-part bridging trial for its lead gout therapy XRx-026, following FDA Type B feedback, targeting a US$700 million market and NDA submission within 18 months.
XORTX has appointed Mika Grasso, age 28, as co-CEO responsible for finance and markets, leveraging his investment and banking background to enhance c-suite effectiveness. This leadership change follows recent financing aimed at restructuring corporate and issuer status to optimize public market efficiency.
Following FDA Type B feedback, XORTX is preparing an IND and a proposed two-part clinical study to characterize steady-state pharmacokinetics of XORLO and evaluate its therapeutic equivalence to allopurinol. Data from these studies will support a 505(b)(2) NDA submission for XRx-026, with marketing approval targeted within 18 months.
The company is targeting a US$700 million per year gout market for patients intolerant to allopurinol while advancing its ADPKD candidate XRx-008 and other investigational programs. Parallel chemistry, manufacturing and control activities, along with potential collaborations or in-licensing, aim to maximize commercialization potential and shareholder value.
