Unicycive(US:UNCY) Globenewswire·2026-01-29 12:05Core Viewpoint - Unicycive Therapeutics has received FDA acceptance for the resubmission of its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, with a target action date set for June 27, 2026 [1][9]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney diseases, with its lead investigational treatment being oxylanthanum carbonate [8]. - The company also has a second investigational treatment, UNI-494, which is intended for conditions related to acute kidney injury and has received orphan drug designation from the FDA [8]. Product Details - OLC is designed to reduce the number and size of pills required for treating hyperphosphatemia, potentially improving patient adherence compared to existing treatments [4]. - The NDA for OLC is supported by data from three clinical studies and various preclinical studies, with no concerns raised by the FDA regarding the safety or efficacy data [2]. Financial Position - As of the end of 2025, the company reported an unaudited cash position of $41.3 million, which is expected to support its commercial launch activities and provide a cash runway into 2027 [3][9]. Regulatory Pathway - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, backed by a strong global patent portfolio that includes exclusivity until 2031, with potential extensions until 2035 [5]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease, with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [6].