DURHAM, N.C. and NESS ZIONA, Israel, Dec. 10, 2020 /PRNewswire/ -- Atox Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted to file the New Drug Application (NDA) for reltecimod with a Prescription Drug User Fee Act (PDUFA) date of September 30, 2021. The proposed indication is for the treatment of suspected organ dysfunction or failure in patients ?12 years of age with NSTI, in conjunction with surgical debridement, antibiotic therapy, and supportive care. If approved, reltecimod could advance the standard of care for patients with NSTI by providing a novel treatment option for these patients.