CORMEDIX INC · Data as of 2026-09-08
Q3 2026
CorMedix announced today that in collaboration with our global development partner Mundipharma, the company anticipates FDA submission of the sNDA for an expanded indication of REZZAYO for the prophylaxis of invasive fungal disease in the third quarter of this year.Source filing
2H26
The companies anticipate a pre-NDA submission meeting with FDA in the coming months, followed by a target submission of a supplemental New Drug Application (sNDA) to the FDA in 2H26 based on the ReSPECT results.Source filing
1H 2027
– DefenCath ® (taurolidine and heparin) TPN indication would add an estimated 5MM annual infusions in the addressable market opportunity, an addressable market of ~$500 - $750MM data in 1H 2027Source filing
H1 2027
Provided the application is accepted for FDA review, the Company anticipates agency action on the application in H1 2027.Source filing
Jun 30
Upon the issuance of the U.S. Food and Drug Administration ("FDA") marketing approval of (a) the product known as REZZAYO TM (rezafungin) as of the date hereof or as may be modified thereafter, or (b) any product that contains the active ingredient rezafungin, for the prevention or prophylaxis of invasive fungal infections in adult patients undergoing allogeneic stem cell blood and marrow transplant or the regulatory equivalent on or prior to June 30, 2029, the Company shall pay, in cash or common shares, par value $0.001 per share, of the Company ("Common Stock") at the Company's election, to the Contingent Payment Holders and certain Company Optionholders the following payments:Source filing