On March 17, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has extended its review of the New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide) by three months to June 29, 2026.

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The extension and revised target Prescription Drug User Free Act (PDUFA) goal date of June 29, 2026, will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501.

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is currently under evaluation by the FDA as a radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

(Press release, Lantheus, MAR 17, 2026, View Source [SID1234663618])