CorMedix and Mundipharma announced positive topline results from the Phase III ReSPECT trial on April 27, 2026, showing REZZAYO (rezafungin) met its primary endpoint of non-inferiority for fungal-free survival at Day 90:
60.7% vs. 59.0% for standard antimicrobial regimen.12
The trial evaluated once-weekly rezafungin for prophylaxis of invasive fungal diseases (Candida, Aspergillus, Pneumocystis) in adult allogeneic HSCT patients across 50+ centers in seven countries, demonstrating comparable efficacy, mortality, and a favorable safety profile with fewer toxicity-related discontinuations and reduced drug-drug interactions.123
Mundipharma sponsored the trial; plans include sNDA submission to FDA in 2H 2026 and EMA submission in Q3 2026.12
Sources:
1. https://www.stocktitan.net/news/CRMD/cor-medix-therapeutics-announces-positive-topline-results-from-phase-yo1snbu5ccbu.html
2. https://www.businesswire.com/news/home/20260427620065/en/Mundipharma-announces-positive-topline-results-from-Phase-III-ReSPECT-trial-assessing-REZZAYO-rezafungin-for-the-prophylaxis-of-invasive-fungal-diseases-in-allogeneic-haematopoietic-stem-cell-transplantation-patients
3. https://www.afp.com/en/infos/mundipharma-announces-positive-topline-results-phase-iii-respect-trial-assessing-vrezzayor