Unicycive Says FDA Issues CRL For Oxylanthanum Carbonate For Hyperphosphatemia In CKD Patients

Unicycive Therapeutics received an FDA Complete Response Letter (CRL) for the resubmitted NDA for oxylanthanum carbonate (OLC). A CRL typically indicates the FDA cannot approve the application in its current form, adding delay and uncertainty around the path to approval. The news is likely a negative catalyst for UNCY given the regulatory setback.

Analysis

Unicycive Therapeutics received an FDA Complete Response Letter (CRL) for the resubmitted NDA for oxylanthanum carbonate (OLC). A CRL typically indicates the FDA cannot approve the application in its current form, adding delay and uncertainty around the path to approval. The news is likely a negative catalyst for UNCY given the regulatory setback.