07:12 AM EDT, 06/10/2025 (MT Newswires) -- Unicycive Therapeutics ( UNCY ) said Tuesday that the US Food and Drug Administration identified deficiencies in current good manufacturing practices, or cGMP, at a third-party manufacturing site related to its new drug application for oxylanthanum carbonate.

Oxylanthanum carbonate is a potential treatment for hyperphosphatemia in dialysis patients with chronic kidney disease.

The FDA informed the company that it would not engage in labeling discussions due to the identified deficiencies and will make a final decision by the Prescription Drug User Fee Act action date of June 28.

CEO Shalabh Gupta said the company is working with partners to address the FDA's concerns and "remain confident in the promise of OLC based on the extensive clinical and preclinical data we've generated."

Unicycive shares were down over 35% in recent premarket activity.