Mundipharma and CorMedix announce the victory of the antifungal drug Rezzayo in preventing invasive fungal disease in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT).
In the Phase 3 ReSPECT study, Rezzayo met its primary endpoint by demonstrating noninferiority to standard antimicrobial regimens (SARs) in keeping stem cell transplant patients alive and protecting them from fungal infections such as Candida, Aspergillus, and Pneumocystis.
Patients undergoing allogeneic blood and bone marrow transplants face long periods of immunosuppression to manage graft-versus-host disease, making them more susceptible to these infections.
In the study, which included patients at 50 sites in seven countries, Rezzayo showed a 90-day sterile survival rate of 60.7%, compared to 59% for patients receiving SAR treatment. Additionally, the results showed a favorable profile in multiple secondary endpoints, including adverse events leading to dose reduction, interruption, or discontinuation of the study drug, CorMedix said on Monday.
“These findings represent meaningful progress in advancing the treatment of this vulnerable population,” Yuri Martina, MD, Mundipharma’s chief development medical officer, said in the release. “Rezafungin has the potential to change the standard of care for these patients,” he added, using the drug’s generic name.
The companies plan to meet with the FDA in the coming months to discuss the results and plan to submit an application for U.S. approval in the second half of this year.
Mundipharma added that it also plans to submit an application for review to the European Medicines Agency by the third quarter of this year.
San Diego biotech company Cidara won FDA approval for Rezzayo in 2023. Weekly echinocandin injections were approved not only for invasive candidiasis but also for candidemia, a serious bloodstream infection that can occur in hospitalized patients and be fatal.
Following approval, Cidara received a $20 million milestone payment from private Melinta Therapeutics, which paid $30 million for the U.S. licensing rights. Last August, Cormedix paid $300 million to acquire neighboring New Jersey-based Melinta and its portfolio of seven drugs, six for infectious diseases.
Mundipharma has owned the commercial rights to Rezayo outside the United States since its approval and took control of the drug’s assets and rights in April 2024.
CorMedix reported overall sales of $312 million in 2025, of which DefenCath, a catheter-related bloodstream infection prevention drug, accounted for $168 million.
