FDA accepts CorMedix sNDA for Rezzayo, grants priority review

CorMedix announced on October 19, 2026 that the FDA accepted for filing a supplemental New Drug Application for REZZAYO (rezafungin for injection) for the prophylaxis of invasive fungal disease.¹

The application was filed by Mundipharma, CorMedix's global development partner, and the FDA granted priority review with a PDUFA target action date in the first quarter of 2027.¹ The filing rests on the Phase III ReSPECT study, which tested once-weekly rezafungin against a standard antimicrobial regimen for preventing invasive fungal disease in adults undergoing allogeneic hematopoietic stem cell transplant, with CorMedix reporting positive topline results in April.¹ If the new indication is approved, CorMedix said it is targeting a promotional launch beginning in the second half of 2027.¹

CEO Joseph Todisco called the acceptance "an important regulatory milestone for CorMedix, REZZAYO, and for patients who remain at risk for invasive fungal disease,"¹ according to the release.

Rezafungin currently holds FDA approval under the brand Rezzayo for treatment of candidemia and invasive candidiasis in adults and pediatric patients age 12 and older who have limited or no other treatment options.¹ The company noted that the drug is not yet approved for prophylaxis of invasive fungal disease, and the FDA has not established its safety or effectiveness for that use.¹ Rezafungin carries orphan drug exclusivity through 2035 and patent protection through 2038 in the United States.¹

CorMedix cautioned that acceptance for filing and priority review do not guarantee approval,¹ and that outcomes could change as more data become available.