Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases
Key Highlights
- ➤FDA accepts REZZAYO sNDA for invasive fungal disease prophylaxis
- ➤Priority Review sets Q1 2027 PDUFA target action date
- ➤ReSPECT Phase III study supported the supplemental application
- ➤CorMedix targets promotional efforts beginning in H2 2027 if approved
Expert Statements
Joseph Todisco, Chairman & Chief Executive Officer of CorMedix
“The FDA’s acceptance of this supplemental application for Priority Review is an important regulatory milestone for CorMedix, REZZAYO, and for patients who remain at risk for invasive fungal disease”
Joseph Todisco, Chairman & Chief Executive Officer of CorMedix
“We are grateful to the patients, investigators and clinicians who participated in ReSPECT and to our partner, Mundipharma, for their contributions in reaching this point”
Joseph Todisco, Chairman & Chief Executive Officer of CorMedix
“We look forward to working closely with Mundipharma in the coming months ahead of FDA’s action date and will begin to prepare for a potential promotional launch in the second half of 2027”
PARSIPPANY, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) seeking approval of REZZAYO(® )(rezafungin for injection) for the prophylaxis of invasive fungal disease. The sNDA was submitted by Mundipharma, CorMedix’s global development partner, and the FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027. The sNDA is supported by the Phase III ReSPECT pivotal study, for which CorMedix announced positive topline results in April. ReSPECT evaluated the efficacy and safety of once weekly rezafungin (rezafungin acetate) compared with a standard antimicrobial regimen (SAR) for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT. If REZZAYO is approved for this new indication, CorMedix is targeting to begin promotional efforts beginning in H2 2027.
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