Unicycive Therapeutics Inc. has released a corporate presentation detailing its progress in developing novel treatments for kidney diseases. The company’s lead asset, oxylanthanum carbonate (OLC), is being advanced for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. The OLC New Drug Application (NDA) was resubmitted to the FDA following the resolution of a manufacturing-related deficiency, and the FDA has assigned a PDUFA date of June 29, 2026. Unicycive reports a cash runway extending into 2027 to support the application resubmission, potential FDA approval, and commercial launch activities. The company also highlights ongoing development of UNI-494, targeting acute kidney injury and chronic kidney disease. OLC is being developed under the FDA’s 505(b)(2) regulatory pathway and, if approved, will offer a formulation that is swallowed whole, differing from the reference-listed drug Fosrenol. The presentation notes that the market opportunity for hyperphosphatemia treatment in the US exceeds $1 billion, with over 450,000 dialysis patients currently receiving phosphate binders. You can access the full presentation through the link below.

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