The FDA has granted priority review for Defencath™ and has set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021

Defencath™ , an investigational drug product, is a novel, antimicrobial and antifungal solution being developed for the prevention of catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter.

Defencath™, an investigational drug product, was granted FDA Fast Track status and is designated as a Qualified Infectious Disease Product.