Rezzayo passed phase 3. The $300 million CorMedix paid for Melinta in August 2025 isn’t looking like an overpay.
The ReSPECT trial, run across 50 centers in seven countries, showed Rezzayo non-inferior to a standard antimicrobial regimen in keeping allogeneic stem cell transplant patients alive and free of invasive fungal infections, including those from Candida, Aspergillus, and Pneumocystis. Rezzayo hit 60.7% fungal-free survival at Day 90 versus 59% for the standard regimen, and secondary endpoints on adverse events, including dose reductions, interruptions, and drug withdrawals, also favored the drug.
Allogeneic stem cell transplant patients face prolonged immunosuppression to manage graft-versus-host disease, leaving them vulnerable to exactly these pathogens.
CorMedix and partner Mundipharma plan to meet with FDA in the coming months; they’ll file a U.S. approval application in H2 2026. Mundipharma will also file with the European Medicines Agency by Q3 2026. Mundipharma has held ex-U.S. commercial rights to Rezzayo since FDA cleared the drug in 2023 for candidemia and invasive candidiasis, and took full control of the assets in April 2024.
Cidara collected a $20 million milestone when FDA cleared Rezzayo in 2023; Melinta had paid $30 million for the U.S. licensing rights before CorMedix bought the whole company for $300 million. CorMedix reported $312 million in overall sales for 2025, with DefenCath, its catheter-infection preventative, accounting for $168 million of that figure.
The U.S. filing opens H2 2026.
Sarah Chen