Other Events ·
FDA grants Priority Review for CorMedix REZZAYO sNDA, targeting action in Q1 2027
CRMDCorMedix Inc.
The U.S. Food and Drug Administration has accepted for filing a supplemental New Drug Application (sNDA) seeking approval of REZZAYO (rezafungin) for the prophylaxis of invasive fungal disease. The FDA granted Priority Review status, establishing a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027. The application is supported by positive topline results from the Phase III ReSPECT pivotal study. CorMedix plans to begin promotional efforts for a potential launch in H2 2027 if approved. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products.