XORTX Provides Corporate Update and Planned Activities for 2025 / 2026

Core Insights - XORTX Therapeutics Inc. is advancing its lead gout program, XRx-026, with a focus on filing a New Drug Application (NDA) within approximately 12 months, targeting a market opportunity of USD $700 million annually [3][6][8] Group 1: Strategic Focus and Achievements - The company has prioritized the XRx-026 gout program, leveraging advancements in the proprietary XORLO™ formulation, which demonstrates increased oral bioavailability [2][4] - Significant achievements in 2025 include the validation of the XORLO™ formulation and progress in both the XRx-026 and XRx-008 programs [5][6] - Engagement with the FDA through a Type B meeting has clarified the regulatory path for NDA submission via the 505(b)(2) pathway [6] Group 2: Goals and Future Plans - Key objectives for 2025/2026 include advancing the XRx-026 program and preparing for NDA filing, alongside conducting clinical trials to support regulatory submissions [6][12] - The company plans to pursue both non-dilutive and dilutive funding, and is actively seeking partnerships with major pharmaceutical and biotech companies to accelerate commercialization [7][8] - Preparations for commercialization will include market studies and engagement with healthcare professionals to analyze pricing and branding strategies [12]