LNTH-2501 (Gallium-68 edotreotide)

June 26, 2026: Lantheus Holdings, Inc. (NASDAQ: LNTH) said the FDA issued a Complete Response Letter (CRL) for its NDA for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit for localization of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs) in adult and pediatric patients. The FDA stated it cannot approve the NDA by the June 29, 2026 PDUFA action date due to unresolved manufacturing-related conditions at a third-party facility responsible for drug product manufacturing; the NDA may be approved after satisfactory resolution of the facility inspection-related conditions. The CRL did not cite concerns with the application’s submitted data or identify safety or efficacy issues for LNTH-2501. Lantheus said it is working with its manufacturing partner and the FDA to address the facility conditions and advance the program.