CorMedix Receives FDA Priority Review for Rezzayo Fungal Disease Prevention

08:48 AM EDT, 10/19/2026 (MT Newswires) -- CorMedix (CRMD) said Monday that the US Food and Drug Administration, or FDA, granted priority review to its supplemental new drug application seeking approval of Rezzayo for the prevention of invasive fungal diseases. The company said the FDA assigned it a Prescription Drug User Fee Act target action date in Q1 2027. CorMedix said the application is supported by data from the third phase of its ReSPECT study. Rezzayo is indicated for adults and pediatric patients aged at least 12 years without alternative options for the treatment of candidemia and invasive candidiasis, it said. The drug is not currently approved for preventing invasive fungal diseases, and its safety and efficacy for that use have not been established, the company said. The company said that, subject to approval, it expects to begin promotional efforts in the second half of next year.