Xortx Therapeutics announces planned goals for 2026

XORTX Therapeutics (XRTX) provides a comprehensive update on its 2025 progress and strategic goals for 2026. The company said, “Looking ahead, XORTX is focused on advancing XORLO within the XRx-026 program toward a NDA filing and market approval within approximately 12 months. Our key objectives include: Investigational New Drug Application:We will prepare and submit an INDapplication to the FDA, incorporating novel formulation data, pharmacology, toxicology, and clinical results from the XRX-OXY-101 trial to support further clinical studies. XRX-OXY-102 Clinical Trial:We plan to initiate a clinical trial in the second half of 2025 to study XORLO pharmacokinetics in fed and fasted states… Chemistry, Manufacturing, and Controls:In parallel with items 1 and 2, we will produce clinical drug supplies under the IND, scale up commercial supplies, and conduct validation and stability testing for XORLO, adhering to GMP standards to support our planned NDA filing. Commercialization Preparations:To prepare for a potential 2026 NDA filing under the FDA’s 505(b)(2) pathway, we will conduct commercialization studies, including interviews with nephrologists, patients, and payers to analyze pricing, reimbursement, and branding strategies… European Market Strategy:We will engage with the EMA to define the regulatory path for XORLO approval in the European Union, including necessary clinical studies and reimbursement conditions, with activities ongoing through 2025/2026.”