Unicycive Therapeutics Inc. released a corporate presentation outlining its kidney disease pipeline, led by oxylanthanum carbonate (OLC), an investigational treatment for hyperphosphatemia in chronic kidney disease patients on dialysis being developed under the FDA 505(b)(2) pathway. The company said the FDA accepted its OLC NDA resubmission and assigned a PDUFA date of June 29, 2026, following a prior complete response letter tied to third-party manufacturing vendor compliance. The presentation also highlighted launch readiness priorities, including market awareness, reimbursement, and commercial logistics, and noted UNI-494 in development for acute kidney injury. You can access the full presentation through the link below.
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