Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems

Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time.

The FDA cited ongoing problems at a third-party contract manufacturer, indicating that the manufacturing deficiencies have not been resolved since the first complete response letter.

The repeated CRL delays the drug's potential market entry and underscores the importance of reliable manufacturing partners for biotech firms developing renal therapies.