Unicycive Therapeutics (NASDAQ:UNCY), a clinical-stage biotechnology company focused on kidney disease therapies, today announced a significant update regarding its New Drug Application (NDA) for oxylanthanum carbonate (OLC), a treatment for hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis.
The U.S. Food and Drug Administration (FDA) has informed Unicycive that it identified deficiencies in current Good Manufacturing Practices (cGMP) compliance at a third-party manufacturing vendor.
This vendor is a subcontractor to one of Unicycive's Contract Development and Manufacturing Organizations (CDMOs) and is not the company's Drug Substance vendor.
As a direct consequence of these identified deficiencies, the FDA has stated that it is precluded from engaging in any label discussions with Unicycive Therapeutics at this time.
Unicycive Therapeutics has confirmed that it has responded to all information requests from the FDA and continues to anticipate a final decision from the regulatory agency by the PDUFA (Prescription Drug User Fee Act) action date of June 28, 2025.