The FDA notified Lantheus of a standard three-month extension for the PDUFA review of its NDA for LNTH-2501, moving the target action date to June 29, 2026. This extension is specifically to allow additional time for review of manufacturing-related documentation and does not reflect concerns about the product’s safety or efficacy data.

The three-month delay pushes the earliest possible U.S. launch of LNTH-2501 into the third quarter, potentially deferring related revenue and affecting short-term financial forecasts. Budget planning and investor expectations may need adjustment as clinical partners and radiopharmacies await final approval and supply chain readiness.

LNTH-2501 is supplied as a two-vial kit designed for on-site preparation of Ga 68 edotreotide PET injections, targeting somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients. Once approved, the kit will enable radiopharmacies to label Gallium-68 from local generators without relying on pre-manufactured doses.