regulatory
confidence high
sentiment positive
materiality 0.60
CorMedix FDA accepts REZZAYO sNDA for fungal prophylaxis with Priority Review; PDUFA set for Q1 2027
CorMedix Inc.
- FDA accepted for filing the sNDA, submitted by partner Mundipharma, for REZZAYO (rezafungin) prophylaxis of invasive fungal disease in adults undergoing allogeneic HSCT.
- Priority Review granted with a PDUFA target action date in Q1 2027; CorMedix targets beginning promotional efforts in H2 2027.
- sNDA supported by the Phase III ReSPECT pivotal study, for which CorMedix reported positive topline results in April 2026.
- Rezafungin holds U.S. orphan drug exclusivity through 2035 and patent coverage through 2038; REZZAYO is already approved for candidemia and invasive candidiasis.
- Company cautions acceptance and Priority Review do not assure approval; FDA could request more data, extend review, or grant narrower labeling.