CorMedix reports positive Phase III trial results for REZZAYO fungal prophylaxis

CorMedix Therapeutics (NASDAQ: CRMD) announced that its Phase III ReSPECT trial met its primary endpoint, demonstrating non-inferiority of REZZAYO compared to standard antimicrobial regimens for preventing invasive fungal diseases in stem cell transplant patients.

The global, randomized, double-blind study evaluated once-weekly rezafungin against standard antimicrobial regimens in adults undergoing allogeneic hematopoietic stem cell transplantation. The trial showed 60.7% fungal-free survival at day 90 for rezafungin compared to 59.0% for standard treatment.

The study assessed prevention of infections caused by Candida, Aspergillus, and Pneumocystis pathogens. Results showed comparable efficacy against invasive infections and mortality rates in both treatment groups. Secondary endpoints demonstrated favorable outcomes for treatment-related adverse events leading to dose modifications and study discontinuations.

Mundipharma sponsored the clinical trial and holds commercial rights to rezafungin outside the United States. The company has partnered with Melinta Therapeutics, a wholly owned subsidiary of CorMedix, for US distribution.

The companies plan to meet with the FDA in coming months and target submission of a supplemental New Drug Application in the second half of 2026 based on the ReSPECT results.

Rezafungin is currently approved for treating candidemia and invasive candidiasis in adults. The drug has orphan drug exclusivity through 2035 and patent coverage through 2038 in the United States. CorMedix estimates the potential US market opportunity for prophylaxis use exceeds $2 billion, though this figure represents internal projections subject to regulatory approvals and market adoption.

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