CorMedix's REZZAYO Phase III Trial Hits Primary Endpoint for Fungal Prophylaxis, Targets $2B Market Expansion
Summary
CorMedix Therapeutics announced positive topline results from its Phase III ReSPECT trial for REZZAYO, demonstrating non-inferiority against standard antimicrobial regimens for the prophylaxis of invasive fungal diseases in allogeneic hematopoietic stem cell transplantation patients. The study successfully met its primary endpoint for fungal-free survival at Day 90, and REZZAYO showed a favorable safety profile with fewer toxicity-related discontinuations and drug-drug interactions. This outcome significantly expands the potential market for REZZAYO, with CorMedix estimating the US prophylaxis market opportunity to exceed $2 billion. The company plans a pre-NDA meeting with the FDA in the coming months, targeting a supplemental New Drug Application (sNDA) submission in the second half of 2026, which will be a key catalyst for the stock.
At the time of this announcement, CRMD was trading at $7.47 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $581.9M. The 52-week trading range was $6.13 to $17.43. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.