Why Is Unicycive Therapeutics Stock Falling Tuesday?

Unicycive Therapeutics, Inc. (NASDAQ: UNCY ) on Monday said the U.S. Food and Drug Administration has issued a Complete Response Letter (CRL) for its resubmitted New Drug Application (NDA) seeking approval of oxylanthanum carbonate (OLC) for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Following the announcement, the stock fell over 46%. The company said the agency’s decision was once again tied to third-party manufacturing deficiencies rather than concerns over the drug’s efficacy or safety. Read Also: FDA Raises Manufacturing Concerns, Delays Unicycive's Kidney Disease Drug Approval FDA Repeats Prior Manufacturing Concerns According to the company, the latest CRL stems from the same manufacturing-related deficiencies identified in the agency’s June 2025 response. Unicycive said the FDA did not request additional clinical data an...