Wednesday, September 04, 2024
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Unicycive Announced Submission Of The OLC Application For Approval. Unicycive has announced that its New Drug Application (NDA) for its phosphate binder OLC (oxylanthanum carbonate) has been submitted to the FDA. This is consistent with our expectations after data from the last clinical study showing efficacy in treating high phosphate levels in chronic kidney disease (CKD) patients on dialysis. We continue to anticipate product approval in 2Q25.
We Believe Dosing and Efficacy Could Make OLC The Leading Phosphate Binding Drug. OLC was developed with proprietary nanoparticle technology to reduce the daily number of pills to just one three times a day for a full dose. This gives an advantage over other phosphate binders, which require 9 to 12 pills each day. Its formulation is based on lanthanum, the active entity in the approved drug Fosrenol. We expect this to be a strong advantage for OLC.
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