Unicycive Stock Plunges 8.09% Ahead of FDA Decision

On June 17, 2025, Unicycive's stock experienced a significant drop of 8.09% in pre-market trading, reflecting investor concerns and market sentiment ahead of the FDA's decision on its lead drug candidate, Oxylanthanum Carbonate.

Unicycive Therapeutics is awaiting the FDA's decision on June 28, 2025, for its drug Oxylanthanum Carbonate, which is proposed for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. Hyperphosphatemia is a common and serious condition in nearly all patients with End Stage Renal Disease (ESRD), and if left untreated, it can lead to secondary hyperparathyroidism and cardiovascular complications. The company believes that if approved, Oxylanthanum Carbonate could improve patient adherence due to its convenient dosing and administration.

Unicycive's stock performance is closely tied to the regulatory decisions on its drug candidates. The upcoming FDA decision on Oxylanthanum Carbonate is a critical milestone for the company, and the market's reaction to the pre-market drop suggests that investors are cautious about the potential outcome. The company's ability to navigate the regulatory process and secure approval for its drug candidates will be crucial for its future growth and stock performance.