The FDA issued a CRL for ITM Isotope’s ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors, citing manufacturing issues at a third-party facility rather than concerns about the submitted data package or safety profile. The agency’s late-stage request delays the next step in the approval pathway even as the clinical promise of radiotherapeutics remains intact. Separately, the FDA approved Takeda’s Orzeyful (oveporexton) as the first therapy designed to address the underlying cause of narcolepsy type 1 in adults. The approval follows China’s NMPA clearance in July and establishes a new first-in-class option for a disease area with limited mechanism-directed treatments. On agency process, additional regulatory coverage also points to policymakers pushing faster early-stage trial entry via expedited IND pilots, reflecting renewed momentum on first-in-human trial modernization efforts.