Core Insights - The Phase 2b clinical trial for RAD101 has reached a 50% patient enrollment milestone, indicating progress towards demonstrating its clinical benefits in differentiating tumor recurrence from radiation necrosis in brain metastasis patients [2][6] - Early patient data shows significant and selective tumor uptake in brain metastases, aligning with previous Phase 2a results, which may lead to a global Phase 3 registrational trial if confirmed [3][7] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][9] - The company is listed on ASX (RAD) and NASDAQ (RADX), with a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [9] Clinical Trial Details - The Phase 2b trial is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [6] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging methods [6] Product Information - RAD101 is a novel imaging small molecule targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [2][7] - The product has received FDA Fast Track Designation to help distinguish between recurrent disease and treatment effects in brain metastases [5]