Wednesday, June 26, 2024
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Side Effect Rates Were Low. Unicycive announced top-line results from its pivotal study to determine OLC (oxylanthanum carbonate) tolerability, safety, and dosing. The trial met its tolerability and safety endpoints with data that compares favorably with Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. An NDA filing is expected in 3Q24.
Low Discontinuation Rate Met The Primary Endpoint. Tolerability, the rate of discontinuations due to treatment related adverse events (TRAEs), was the primary endpoint. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, a rate of 1.4%. In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, a rate of 3.5%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.
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