RadioPharm Theranostics reaches 50% enrollment in Phase 2b RAD101 study for imaging brain metastases

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19h ago 5:16

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RadioPharm Theranostics CEO Riccardo Canevari joined Steve Darling from Proactive to announce a significant clinical milestone for the company. Its Phase 2b trial evaluating RAD101, an advanced molecular imaging agent, in patients with brain metastases has now reached 50% patient enrollment, marking strong momentum as the study progresses toward completion. The ongoing U.S. multicenter, open-label, single-arm Phase 2b trial is assessing the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases originating from a range of solid tumors. The trial’s primary endpoint is the concordance between 18F-RAD101–positive lesions and those detected through conventional MRI with gadolinium, the current imaging standard for suspected recurrent disease. Canevari emphasized the importance of this milestone, noting that reaching the halfway point in enrollment represents meaningful progress for the RAD101 program. He added that the study aims to demonstrate RAD101’s potential to distinguish true tumor recurrence from radiation necrosis—a major clinical challenge for patients previously treated with therapeutic radiation. Continued enrollment momentum supports the company’s confidence in completing the trial and reporting topline results in the first half of 2026. RAD101 is RadioPharm’s novel imaging small molecule designed to target fatty acid synthase (FASN), an enzyme that is highly overexpressed in numerous solid tumors, including metastatic lesions in the brain. The program has been further strengthened by the U.S. Food and Drug Administration’s Fast Track Designation, which recognizes the agent’s potential to differentiate recurrent disease from treatment-related effects across multiple tumor types, including leptomeningeal disease. #proactiveinvestors #radiopharmtheranostics #asx #rad #nasdaq #radx

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