Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ:LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the first patient has been dosed in SPARROW NCT07831824, a Phase 2/3 registrational trial evaluating LNTH-2401 (68Ga-DOTA-RM2). LNTH-2401 is an investigational gallium-68-labeled positron emission tomography (PET) imaging agent that targets the gastrin-releasing peptide receptor (GRPR), a biomarker that is highly expressed in many prostate cancers.

SPARROW is an open-label, non-randomized, multicenter Phase 2/3 study that includes an initial Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period. The Phase 3 co-primary endpoints are sensitivity and specificity of LNTH-2401 PET/CT imaging compared with histopathology. The Phase 3 portion of the trial is expected to enroll approximately 400 participants and will evaluate diagnostic performance, safety and tolerability.