0001213900-26-047748
SEC filingCorMedix announced positive Phase III topline results for REZZAYO in prophylaxis of invasive fungal diseases, meeting the primary endpoint of non-inferiority vs. standard regimen.
CorMedix announced positive topline results from the Phase III ReSPECT study evaluating REZZAYO (rezafungin for injection) for prophylaxis of invasive fungal diseases in allogeneic HSCT patients. The study met its primary endpoint of fungal-free survival at Day 90, demonstrating non-inferiority versus standard antimicrobial regimen (60.7% vs 59.0%). Rezafungin also showed a favorable safety profile, particularly in toxicity-related discontinuations and drug-drug interactions. These results position REZZAYO as a potential alternative for prophylaxis if approved. The company plans a pre-NDA meeting with FDA and a supplemental NDA submission in the second half of 2026. CorMedix estimates the US prophylaxis market opportunity exceeds $2 billion, though this is forward-looking. The positive data strengthens REZZAYO's value proposition and expands its potential beyond the current approved indication for candidemia and invasive candidiasis.