Monday, March 11, 2024
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Pivotal Trial Enrollment Complete. Unicycive announced that it has completed enrollment in the pivotal trial testing OLC (oxylanthanum carbonate), its phosphate binder, in ESRD patients on renal dialysis. This is a milestone for the trial that also confirms the timeframes we had expected for the trial results, NDA application, and product launch.
Data and NDA Expected Later In 2024. The pivotal trial is an open-label single arm study. Its primary endpoint is tolerability, with secondary endpoints of safety and pharmacokinetics. Statistical analysis is not required. The trial has a target enrollment of 60 patients and is expected to announce data in late 2Q24/mid2024.
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