Unicycive Therapeutics Provides Update on FDA Meeting and NDA Resubmission

Unicycive Therapeutics, Inc. announced an update from its meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). The company plans to resubmit the NDA by the end of 2025, following the resolution of a manufacturing compliance issue identified in a Complete Response Letter (CRL) received on June 30, 2025. The company also provided preliminary financial results, estimating $42 million in cash and cash equivalents as of September 30, 2025, which is expected to support the regulatory approval process and potential commercialization of OLC. The company anticipates a PDUFA date in the first half of 2026.