Unicycive Stock Plunges 32.22% Amid FDA Manufacturing Concerns

On June 10, 2025, Unicycive's stock plummeted by 32.22% in pre-market trading, marking a significant downturn for the company.

Unicycive Therapeutics has encountered regulatory hurdles with the FDA, which has identified compliance deficiencies at a third-party manufacturing vendor. These issues have halted label discussions for their New Drug Application (NDA) for oxylanthanum carbonate (OLC), a drug intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA's findings have raised concerns about the manufacturing process, despite Unicycive's efforts to address all information requests from the regulatory body. The final decision on the NDA is expected by the PDUFA date of June 28, 2025.

CEO Shalabh Gupta has expressed confidence in the potential of OLC, citing strong clinical and preclinical data. However, the manufacturing setback has cast a shadow over the company's prospects, leading to a significant drop in investor confidence and stock value.