Unicycive(US:UNCY) Globenewswire·2025-12-29 12:05Core Viewpoint - Unicycive Therapeutics has resubmitted its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to the FDA, with a new PDUFA date expected in the first half of 2026, following progress in resolving compliance issues with its manufacturing vendor [1][2]. Group 1: Company Developments - The resubmission of the NDA was made possible due to significant progress by the original third-party manufacturing vendor in regaining FDA compliance [2]. - The company has a cash runway extending into 2027, positioning it well to complete the regulatory approval process for OLC [2]. - The NDA submission package includes data from three clinical studies and is supported by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [5]. Group 2: Product Information - OLC is an investigational oral phosphate binder designed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, utilizing proprietary nanoparticle technology for enhanced phosphate binding potency [4]. - The treatment aims to reduce the pill burden for patients, potentially improving adherence compared to existing options [4]. Group 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 [6]. - Effective treatment of hyperphosphatemia is essential as uncontrolled levels are linked to increased mortality and hospitalization among CKD patients on dialysis [6].