Friday, August 15, 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.
Actions Taken To Correct Manufacturing Findings. Unicycive reported a 2Q25 loss of $6.4 million or $(0.52) per share, with cash on June 30, 2025 of $22.3 million. Based on our current estimates, we believe this is sufficient to fund operations through 2H25. On June 30, the company received a CRL (Complete Response Letter) following an FDA inspection that found deficiencies at a contract manufacturer’s facility. The findings stopped the labeling discussions required for completion of the NDA review. The company has shifted to one of its other manufacturers, and filed a request for a meeting with the FDA.
A Request For A Type A Meeting Was Filed. Following the receipt of the CRL, Unicycive filed a request for a Type A meeting with the FDA. This type of meeting is held to discuss the issues that led to the CRL and how to correct them. These meetings are usually scheduled within 30 days of the request. After meeting is held the company will receive the meeting minutes with requirements for resubmission of the NDA application. Unicycive expects to announce an updated plan for OCL development during 3Q25.
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