Cormedix Priority Review of Supplemental NDA for Prophylaxis of Fungal Disease

CorMedix Therapeutics (Nasdaq: CRMD) announced FDA acceptance for Priority Review of its supplemental application for REZZAYO to prevent invasive fungal disease. Mundipharma, its global development partner, submitted the application, which has an FDA target action date in Q1 2027.

The application is supported by the Phase III ReSPECT study, which compared once-weekly rezafungin with a standard antimicrobial regimen in adults undergoing allogeneic hematopoietic stem cell transplantation, using donor blood-forming cells. CorMedix announced positive topline results in April. The company targets promotional efforts in H2 2027 if the new indication is approved. REZZAYO is already approved for certain patients with candidemia and invasive candidiasis, but is not approved for prevention of invasive fungal diseases.

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