Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

Core Points - The FDA issued a Complete Response Letter (CRL) for Unicycive's New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, citing deficiencies at a third-party manufacturing vendor unrelated to OLC [1][2] - Unicycive has identified a second manufacturing vendor that has already produced OLC drug product, which may help resolve the Clinical Manufacturing and Controls (CMC) issues noted in the CRL [1][3] - The company plans to request a Type A meeting with the FDA to discuss the next steps for addressing the CRL [2] - Unicycive currently has an unaudited cash balance of approximately $20.7 million, with a cash runway expected into the second half of 2026 [1] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead investigational treatment being OLC [8] - OLC is an investigational oral phosphate binder that utilizes proprietary nanoparticle technology to effectively reduce phosphate levels, potentially improving patient adherence due to a lower pill burden compared to existing treatments [4][5] - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio providing exclusivity until 2031, with potential extensions until 2035 [5] Industry Context - Hyperphosphatemia is a serious condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication to manage phosphate levels annually [6] - Treatment strategies for hyperphosphatemia include dietary phosphorus restriction and the use of oral phosphate binding drugs to facilitate the elimination of dietary phosphate [6][7]