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Unicycive Therapeutics develops investigational treatments for kidney diseases, with news centered on its clinical-stage pipeline, regulatory communications, financial results, and investor presentations. Its lead program, oxylanthanum carbonate, is an oral phosphate binder being developed for hyperphosphatemia in chronic kidney disease patients on dialysis, and company updates frequently address NDA activity, chemistry, manufacturing and controls matters, and commercial-readiness planning.
Unicycive also reports developments for UNI-494, a drug candidate for conditions related to acute kidney injury, including its FDA orphan drug designation for prevention of delayed graft function in kidney transplant patients and completed Phase 1 safety work. Recurring announcements include business updates, conference participation, and capital or cash-position disclosures tied to advancing the kidney-disease portfolio.
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Unicycive Therapeutics (Nasdaq: UNCY) announced that two datasets showcasing the safety and potential efficacy of UNI-494 in animal models will be presented at the 60th European Renal Association Congress (ERA 2023) in Milan, Italy, from June 15-18, 2023. The presentations include one on UNI-494's impact on rat respiratory function and another detailing its effect on lowering urinary b2-microglobulin levels. CEO Shalabh Gupta expressed optimism regarding the drug's reno-protective capabilities, particularly for treating acute kidney injury (AKI), a condition lacking FDA-approved therapies. Additionally, the company is developing Renazorb, a phosphate binding agent, with plans to file a New Drug Application (NDA) mid-year.