BRIEF-Unicycive Therapeutics Gets Complete Response Letter From FDA On Resubmitted Oxylanthanum Carbonate NDA

Unicycive Therapeutics

UNCY

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June 30 (Reuters) - Unicycive Therapeutics Inc UNCY.O:

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

Source text: ID:nGNX3zVDRJ

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