CorMedix Therapeutics Says FDA Accepts sNDA Filing Seeking Approval Of REZZAYO For Prophylaxis Of Invasive Fungal Disease; PDUFA Target Action Date Set In Q1 2027

CorMedix Therapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for REZZAYO (rezafungin for injection) aimed at preventing invasive fungal disease. The application, submitted by CorMedix's partner Mundipharma, has been granted Priority Review with a PDUFA target action date set for Q1 2027. This sNDA is backed by positive results from the Phase III ReSPECT study, which assessed the drug's efficacy and safety in adults undergoing allogeneic HSCT. If approved, CorMedix plans to initiate promotional efforts in H2 2027.