Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]