Lantheus Holdings announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding its New Drug Application for LNTH-2501, a PET diagnostic imaging kit for neuroendocrine tumors. The FDA stated it cannot approve the application by the June 29, 2026 action date due to unresolved third-party facility manufacturing-related conditions. The letter did not identify any concerns with the data submitted by Lantheus or any issues related to the safety or efficacy of LNTH-2501. The company is working closely with its partner and the agency to address the facility conditions and advance the program.
Lantheus Holdings IncFDA issued Complete Response Letter for LNTH-2501 due to unresolved third-party facility manufacturing conditions, delaying approval.