Core Insights - Unicycive Therapeutics plans to resubmit its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) by year-end 2025 after receiving constructive feedback from the FDA regarding a previously identified deficiency [1][2] - The company has over $42 million in cash as of September 30, 2025, providing a financial runway into 2027 to support regulatory processes and potential commercialization of OLC [2] - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, leveraging proprietary nanoparticle technology for improved patient adherence [3][4] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead investigational treatment for hyperphosphatemia [6] - The company is also developing UNI-494, aimed at treating conditions related to acute kidney injury, which has received orphan drug designation from the FDA [6] Product Details - OLC utilizes proprietary nanoparticle technology to enhance phosphate binding potency, potentially reducing the pill burden for patients compared to existing treatments [3] - The NDA submission for OLC is based on data from three clinical studies and multiple preclinical studies, with a strong global patent portfolio protecting its composition until at least 2031, with potential extensions until 2035 [3] Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease (ESRD), with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [4]

Core Insights - Unicycive Therapeutics announced new patient-reported outcomes data from its pivotal Phase 2 study of oxylanthanum carbonate (OLC), an investigational treatment for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, which will be presented at the NKF Spring Clinical Meetings [1][4] - OLC utilizes proprietary nanoparticle technology to reduce the number and size of pills, addressing adherence issues in dialysis patients [2][8] Patient-Reported Outcomes - The Phase 2 trial demonstrated high patient satisfaction with OLC compared to prior phosphate binders, with 98% of patients finding OLC easy to take and 89% satisfied with the treatment [6][7] - OLC reduced the pill burden by 50%, with patients taking a median of three tablets per day compared to six tablets of previous phosphate binders [7] Adherence and Preferences - 70% of patients reported consistent adherence with OLC, an increase from 58% adherence to their previous phosphate binders [7] - 79% of patients preferred OLC over their prior medications, highlighting the impact of pill burden on treatment adherence [7][13] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [8] - Despite existing treatments, 75% of U.S. dialysis patients do not achieve target phosphorus levels, indicating a significant unmet need in the market [8] Regulatory Status - Unicycive is seeking FDA approval for OLC with a PDUFA Target Action Date set for June 28, 2025, through the 505(b)(2) regulatory pathway [2][9]