Unicycive Stock Plunges 48.89% Amid FDA cGMP Concerns

On June 10, 2025, Unicycive's stock plummeted by 48.89% in pre-market trading, marking a significant downturn for the company.

The U.S. Food and Drug Administration (FDA) has identified issues with current Good Manufacturing Practice (cGMP) compliance at a third-party vendor responsible for producing Unicycive's hyperphosphatemia treatment. This development has raised concerns about the drug's production quality and regulatory compliance, potentially impacting investor confidence and market sentiment.

The FDA's final decision on the matter is expected by June 28, 2025. The outcome of this regulatory review will be crucial for Unicycive, as it could affect the availability and marketability of its kidney drug. Investors are closely monitoring the situation, as any adverse regulatory action could further impact the company's stock performance and overall market standing.