Tuesday, July 01, 2025
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.
Approval Delay Is Not A Surprise. Unicycive announced that it has received a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). This was expected following the announcement earlier this month stating that the FDA manufacturing inspection had found deficiencies with one of the OLC contract manufacturers. The company has switched to one of its other manufacturers, which we believe can resolve the issues quickly. We see approval possible around 4Q25 to 1Q26.
Plans To Address The Issues. Unicycive plans to hold a Type A meeting with the FDA to determine its requirements for resolution of the issues cited in the CRL. The company’s second manufacturer already produces OLC and has been generating data for FDA certification. This should allow Unicycive to submit any additional data requested quickly to resolve the issue.
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