other material
confidence high
sentiment positive
materiality 0.90
CorMedix reports positive Phase III ReSPECT results for REZZAYO in fungal prophylaxis
CorMedix Inc.
- Primary endpoint met: fungal-free survival at Day 90 was 60.7% for rezafungin vs 59.0% for standard regimen.
- Rezafungin showed favorable safety profile with fewer toxicity-related discontinuations and drug-drug interactions.
- Target supplemental NDA submission to FDA in 2H26 based on ReSPECT results.
- CorMedix estimates US prophylaxis market opportunity for REZZAYO exceeds $2 billion.
- Mundipharma sponsored the trial; holds ex-US rights; Melinta (CorMedix sub) distributes in US.