Core Insights - The FDA has granted Fast Track Designation for RAD101, a novel imaging small molecule developed by Radiopharm Theranostics, aimed at distinguishing between recurrent disease and treatment effects in brain metastases from solid tumors [1][3] - RAD101 targets fatty acid synthase (FASN), which is overexpressed in many solid tumors, including cerebral metastases, potentially improving diagnostic precision for over 300,000 patients diagnosed annually in the U.S. [2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [6] - The company has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [6] Clinical Trial Details - The Phase 2b clinical trial of RAD101 is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases [4] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging (MRI with gadolinium) [4] - Secondary endpoints include the accuracy, sensitivity, and specificity of RAD101 in differentiating tumor recurrence from radiation necrosis in previously treated brain metastases [4] Product Information - RAD101 is designed to allow for more accurate detection of cancer cells by targeting FASN activity, representing a clinically relevant method for imaging brain metastases [5] - Positive data from a Phase 2a imaging trial indicated significant tumor uptake independent of the tumor's origin, suggesting potential for non-invasive prediction of overall survival [5]