LNTH-2501 (Gallium-68 edotreotide)

March 17, 2026: Lantheus Holdings, Inc. (NASDAQ: LNTH) said the FDA extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months, setting a revised PDUFA goal date of June 29, 2026. The company said the extension is to allow additional time for FDA review of further manufacturing-related information it submitted, and is not related to LNTH-2501 efficacy or safety data. LNTH-2501 is being evaluated as a radioactive diagnostic kit for PET localization of somatostatin receptor–positive neuroendocrine tumors (NETs) in adult and pediatric patients; it is not FDA-approved and is not yet available for sale in the U.S.