Manufacturing issues delay regulatory approval
Unicycive Therapeutics Inc. (NASDAQ:UNCY) shares fell 37% on Tuesday after the company disclosed that it had received a Complete Response Letter from the U.S. Food and Drug Administration for its resubmitted New Drug Application covering oxylanthanum carbonate.
The FDA said the application remains affected by deficiencies at a third-party manufacturing facility that were first identified in a Complete Response Letter issued in June 2025. The agency did not inspect the manufacturing site during its review of the resubmitted application.
Importantly, the FDA raised no concerns regarding the drug’s clinical safety or efficacy and did not request any additional clinical data from the company.
Company continues discussions with the FDA
Oxylanthanum carbonate is being developed as a treatment for hyperphosphatemia in patients with chronic kidney disease who are receiving dialysis.
Unicycive said it resubmitted the application after concluding that the third-party manufacturing vendor had made sufficient progress in addressing the previously identified regulatory deficiencies. The company had reviewed those remediation efforts with the FDA during a Type A meeting held in September 2025.
The company also noted that it remains engaged with the FDA on labelling and packaging matters, with its most recent communication from the agency arriving on June 29 regarding carton and container labels.
Clinical package remains unchanged
The New Drug Application is supported by data from three clinical studies, including a Phase 1 trial in healthy volunteers, a bioequivalence study and a tolerability study involving chronic kidney disease patients undergoing dialysis.
The submission also includes preclinical findings together with chemistry, manufacturing and controls data.