Mundipharma and CorMedix have unveiled a win for their antifungal drug Rezzayo at preventing invasive fungal diseases in patients receiving allogeneic hematopoietic stem cell transplants (HSCT).
In the phase 3 ReSPECT study, Rezzayo met its primary endpoint by demonstrating non-inferiority to a standard antimicrobial regimen (SAR) in keeping stem cell transplant patients alive and free of fungal infections, including those caused by Candida, Aspergillus, and Pneumocystis.
Patients undergoing allogeneic blood and marrow transplantation are more susceptible to these infections because they face prolonged periods of immunosuppression to manage graft-versus-host disease.
In the trial, which included patients at 50 centers in seven different countries, Rezzayo conferred 60.7% fungal-free survival at Day 90 versus a 59% figure for those on SAR. In addition, results showed a favorable profile in multiple secondary endpoints, including adverse events leading to dose reduction, interruption or withdrawal of the study drug, CorMedix said Monday.
“These findings represent a meaningful step forward in advancing care for this vulnerable population,” Yuri Martina, M.D., Ph.D., the chief development and medical officer of Mundipharma, said in a release. “Rezafungin holds the potential to change the standard of care for these patients," he added, using the drug's generic moniker.
The companies expect to meet with the FDA in the coming months to discuss the results, with plans to file an application for U.S. approval in the second half of this year.
Mundipharma added that it expects to file for a review from the European Medicines Agency by the year's third quarter, as well.
San Diego biotech Cidara scored FDA approval for Rezzayo in 2023. The once-weekly injected echinocandin was endorsed for candidemia, which is a serious bloodstream infection that can occur in hospitalized patients that can be fatal, as well as invasive candidiasis.
Upon its approval, Cidara received a $20 million milestone payment from private Melinta Therapeutics, which had paid $30 million for licensing rights in the United States. In August of last year, CorMedix paid $300 million to scoop up its New Jersey-based neighbor Melinta and its portfolio of seven medicines, which include six for infectious diseases.
Mundipharma, which has owned commercial rights to Rezzayo outside of the U.S. since its approval, took control of the assets and rights to the drug in April of 2024.
CorMedix reported overall sales of $312 million for 2025, with catheter-related-bloodstream-infections preventative DefenCath accounting for $168 million of that figure.