Unicycive Therapeutics Inc. has provided an update on the regulatory review process for its lead product candidate, Oxylanthanum Carbonate (OLC), following a recent meeting with the U.S. Food and Drug Administration (FDA). The company received a Complete Response Letter in June 2025 due to a manufacturing compliance issue involving a third-party vendor. No concerns were raised regarding the pre-clinical, clinical, or safety data. Unicycive expects to resubmit its New Drug Application for OLC before the end of the year, which could result in a potential FDA decision in the first half of 2026. The company reported having sufficient cash reserves to support its regulatory and commercialization efforts into 2027. No new grant or funding announcement involving Unicycive or multiple organizations was disclosed.