Brief: Unicycive Therapeutics - Crl Cites Deficiencies At Third-Party Manufacturing Vendor Unrelated To Olc
30/06/2025 12:26
June 30 (Reuters) - Unicycive Therapeutics Inc UNCY.O: UNICYCIVE THERAPEUTICS ANNOUNCES RECEIPT OF COMPLETE RESPONSE LETTER FOR OXYLANTHANUM CARBONATE FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE ON DIALYSIS UNICYCIVE THERAPEUTICS INC - CRL CITES DEFICIENCIES AT THIRD-PARTY MANUFACTURING VENDOR UNRELATED TO OLC UNICYCIVE THERAPEUTICS INC - TO REQUEST TYPE A MEETING WITH FDA TO ALIGN ON NEXT STEPS UNICYCIVE THERAPEUTICS INC - SECOND MANUFACTURING VENDOR IDENTIFIED TO RESOLVE CMC ISSUES IN CRL UNICYCIVE THERAPEUTICS INC - NO OTHER CONCERNS STATED IN CRL, INCLUDING PRE-CLINICAL, CLINICAL, OR SAFETY DATA Source text: ID:nGNX4yNhbm Further company coverage: UNCY.O (((( Reuters.briefs@thomsonreuters.com ;));))
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