(RTTNews) - CorMedix Inc. (CRMD), Monday announced positive Phase III topline results from the global ReSPECT clinical trial, evaluating REZZAYO for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation.
The multicenter, randomized, double-blind study evaluated the efficacy and safety of once weekly rezafungin compared with a standard antimicrobial regimen for the prophylaxis of invasive fungal diseases.
The study met its primary endpoint for FDA and EMA for fungal-free survival at Day 90, demonstrating non-inferiority vs. SAR, with 60.7% fungal-free survival at Day 90 for rezafungin compared to 59.0% for the standard antimicrobial regimen.
The results also showed comparable efficacy against invasive infections caused by Candida, Aspergillus, and Pneumocystis in both therapeutic arms, as well as comparable mortality.
Additionally, it demonstrated a favorable profile in multiple secondary endpoints, most notably treatment emergent adverse events leading to dose reduction, interruption or withdrawal of study drug, and treatment emergent adverse events leading to study discontinuation.
The company now expects a pre-NDA submission meeting with FDA in the coming months, followed by a target submission of a supplemental New Drug Application to the FDA in 2H26 based on the ReSPECT results.
In the pre-market hours, CRMD is trading at $7.45, up 0.40 percent on the Nasdaq.
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