Unicycive Therapeutics Inc. Faces Regulatory Hurdle with FDA Complete Response Letter
Unicycive Therapeutics, Inc., a biotechnology company based in Los Altos, United States, specializing in novel therapies for hyperphosphatemia in chronic kidney disease and acute kidney injury patients, has encountered a significant regulatory challenge. On June 30, 2025, the company announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.
The CRL cited deficiencies at a third-party manufacturing vendor, which were unrelated to the OLC product itself. Importantly, the FDA did not express concerns regarding the pre-clinical, clinical, or safety data associated with OLC. In response to the CRL, Unicycive has identified a second manufacturing vendor that has already produced the OLC drug product. This alternative vendor could potentially address the Clinical Manufacturing and Controls (CMC) issues highlighted in the CRL.
In an effort to swiftly address the FDA’s concerns, Unicycive plans to request a Type A meeting with the agency to align on the next steps. The company’s proactive approach aims to resolve the manufacturing issues and advance the NDA process for OLC.
Financially, Unicycive reported an unaudited cash balance of approximately $20.7 million as of the announcement date, providing a runway to address the current challenges. However, the news of the CRL has impacted the company’s stock performance. Unicycive’s shares fell following the announcement, reflecting investor concerns over the regulatory setback.
As of June 26, 2025, Unicycive’s stock closed at $6.8, with a 52-week high of $11 on June 8, 2025, and a 52-week low of $2.02 on August 12, 2024. The company, listed on the Nasdaq under the ticker UNCY, continues to navigate the complexities of bringing innovative therapies to market while addressing regulatory requirements.
Unicycive’s commitment to resolving the issues identified in the CRL and its strategic planning to engage with the FDA underscore its dedication to advancing treatments for patients with chronic kidney disease. The company’s next steps will be closely watched by investors and stakeholders in the healthcare sector.