FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical therapy candidate for neuroendocrine tumors after manufacturing problems surfaced during review. The decision delays a potential competitor to Novartis’ approved Lutathera and affects ITM’s program for gastroenteropancreatic neuroendocrine tumors. ITM said the FDA cited manufacturing issues in its rejection. Radiopharmaceutical development increasingly hinges on tight quality systems and reproducible production conditions; this setback underscores the execution risk for isotope-based oncology assets. —