Friday, January 30, 2026
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 Announced FDA Acceptance Of The NDA. Unicycive announced FDA acceptance of its resubmission of the New Drug Application (NDA) for OLC (oxylanthanum citrate). The resubmitted application has been classified as a Class II complete response, with a six-month review period. June 29, 2026 is the new PDUFA date, the statutory date for the application to be answered. This is consistent with our expected timeframe for OLC approval and launch.
We See NDA Acceptance As A Significant Milestone. In June 2025, an FDA manufacturing inspection found compliance deficiencies at the facility of a contract manufacturer. This stopped the NDA approval process just weeks before the PDUFA (Prescription Drug User Fee Act) date of June 28, 2025. The review of the preclinical, clinical, safety, and manufacturing data had been completed. We believe this will result in prompt approval.
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