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.
