Garching / Munich, Germany and Princeton, New Jersey, August 10, 2026 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on August 7, 2026, regarding its New Drug Application (NDA) for 177Lu-edotreotide (ITM-11), an investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).