XORTX Provides Update on FDA Type B Meeting Request

Core Viewpoint - XORTX Therapeutics Inc. is advancing its new drug application (NDA) for XORLO™, a proprietary formulation of oxypurinol aimed at treating gout, following guidance from the FDA on key steps necessary for the filing [2][4]. Company Developments - XORTX has received responses from the FDA clarifying the steps needed for the NDA submission for its XRx-026 program targeting gout [2][4]. - The company plans to finalize meeting minutes with the FDA, prepare an Investigational New Drug (IND) application, characterize pharmacokinetics, manufacture commercial supplies, and file the NDA [3][4]. - The NDA for XORLO™ is anticipated to be filed in the first half of 2026, emphasizing the company's commitment to addressing the unmet medical needs of gout patients [4]. Market Context - Approximately 44 million individuals in the US have elevated uric acid levels, with gout affecting about 9.2 million people, indicating a significant market opportunity for gout treatments [5]. - Current treatments include xanthine oxidase inhibitors (XOIs) like allopurinol, which is prescribed to around 3.3 million patients annually in North America, but some patients cannot tolerate it [6]. - XORLO™ aims to fill the gap left by existing treatments, particularly after the decline in the use of Febuxostat due to safety concerns [6].