CorMedix Therapeutics (Nasdaq: CRMD) announced on October 19, 2026, that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental New Drug Application (sNDA) for REZZAYO (rezafungin for injection). The application seeks approval for the prophylaxis of invasive fungal diseases.
The sNDA was submitted by CorMedix’s global development partner, Mundipharma. The FDA has granted Priority Review status to the application, which carries a Prescription Drug User Fee Act (PDUFA) target action date in the first quarter of 2027.
The application is supported by the Phase III ReSPECT pivotal study. This study evaluated the efficacy and safety of once-weekly rezafungin compared to a standard antimicrobial regimen for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic hematopoietic stem cell transplantation (HSCT). CorMedix announced positive topline results for the ReSPECT study in April.
REZZAYO is currently approved by the FDA for the treatment of candidemia and invasive candidiasis in adults and pediatric patients 12 years of age or older who have limited or no alternative treatment options. The drug is not currently approved for prophylaxis. Rezafungin has orphan drug exclusivity through 2035 and patent coverage through 2038 in the United States.
If REZZAYO is approved for the new indication, CorMedix stated its intention to begin promotional efforts in the second half of 2027.
