Unicycive provides update on meeting with FDA, resubmission of NDA for OLC

Unicycive Therapeutics (UNCY) announced an update from its meeting with the U.S. Food and Drug Administration, FDA, and timing of the resubmission of its New Drug Application, NDA, for Oxylanthanum Carbonate, OLC, following receipt of a Complete Response Letter, CRL, on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to the Company, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, the Company plans to resubmit the NDA for OLC by year-end.