CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company is primarily dedicated to advancing its lead investigational drug product, Defencath™, a novel antimicrobial and antifungal solution designed to prevent catheter-related bloodstream infections (“CRBSI”) in end-stage renal disease patients undergoing hemodialysis via central venous catheters. Recently, the company submitted a New Drug Application (NDA) for Defencath™ to the Food and Drug Administration (FDA). Based on the Fast Track designation and Qualified Infectious Disease Product (QIDP) status granted by the FDA to Defencath, the company has requested priority review for the NDA. The FDA aims to complete the review period for priority reviews within 6 months, compared to 10 months for standard reviews. Defencath™ is already marketed in Europe and other regions under the brand name Neutrolin as a CE-marked product.