Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

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]