Wednesday, October 29, 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.
Unicycive Expects To Resubmit Its Application Before YE2025. Unicycive announced plans to resubmit its application for OLC (oxylanthanum carbonate) approval before the end of 2025. This follows a meeting with the FDA to identify and resolve issues that resulted in the Complete Response Letter (CRL) in June 2025. This timeframe is consistent with our expectations for resubmission. We continue to expect OLC to be approved by mid-2026.
Resubmission Announcement Follows An FDA Meeting. In early June 2025, Unicycive announced that a manufacturing inspection found deficiencies at a contract manufacturer’s facility. These inspections were one of the last steps toward approval of the New Drug Application (NDA), but the findings stopped the review process. Following the announcement, the company received a CRL on its PDUFA date of June 30, 2025.
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