Unicycive Therapeutics Inc. Faces Major Setback Due to FDA Manufacturing Deficiencies
Unicycive Therapeutics Inc., a biotechnology company based in Los Altos, United States, experienced a significant decline in its stock price on June 10, 2025, following an announcement from the Food and Drug Administration (FDA). The company’s stock (NASDAQ: UNCY) dropped by 35% due to identified deficiencies at one of its third-party manufacturing vendors. This development has led to a delay in the New Drug Application (NDA) for oxylanthanum carbonate (OLC), a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) undergoing dialysis.
The FDA’s findings pertain to non-compliance with current Good Manufacturing Practices (cGMP) at the third-party vendor, which has precluded further discussions regarding the drug’s labeling. This issue has raised concerns about the timeline for the approval of OLC, a key therapy in Unicycive’s pipeline aimed at addressing hyperphosphatemia in CKD and acute kidney injury patients.
As of June 8, 2025, Unicycive’s stock closed at $0.9, marking a significant drop from its 52-week high of $1.1 on the same date. The company’s market capitalization stands at approximately $92.79 million, with a price-to-earnings ratio of -3.61, reflecting the challenges it faces in the current market environment.
The news has been widely reported across financial news platforms, including TipRanks, Grafa, GlobeNewswire, Seeking Alpha, and RTTNews, highlighting the impact of the FDA’s findings on Unicycive’s operations and investor confidence. The company has acknowledged the situation and is working to address the deficiencies to move forward with its NDA process.
Investors and stakeholders are closely monitoring the developments as Unicycive Therapeutics navigates these challenges, with the company’s future prospects hinging on its ability to resolve the manufacturing issues and advance its pipeline therapies.