Unicycive Therapeutics Inc NASDAQ:UNCY:
RECEIVES COMPLETE RESPONSE LETTER FROM FDA REGARDING RESUBMITTED OXYLANTHANUM CARBONATE (OLC) NEW DRUG APPLICATION (NDA)
FDA RAISES NO CONCERNS ON CLINICAL EFFICACY OR SAFETY DATA, NO ADDITIONAL DATA REQUESTED
FDA HAS NOT CONDUCTED INSPECTION OF THIRD-PARTY MANUFACTURING VENDOR FOR RESUBMITTED NDA
FDA CRL BASED ON THIRD-PARTY MANUFACTURING DEFICIENCIES IDENTIFIED IN JUNE 2025
REMAIN CONFIDENT IN EFFICACY SAFETY OF OLC; OPTIMISTIC THAT WE WILL BE ABLE TO EXPEDITIOUSLY RESUBMIT NDA