Core Insights - Radiopharm Theranostics Limited (NASDAQ:RADX) is experiencing a significant increase in stock price, trading at $10.27, up 141.31%, approaching its 52-week high of $11.00 [7] Group 1: Clinical Trial Updates - The company shared interim data from its U.S. Phase 2b imaging trial of RAD 101, which targets fatty acid synthase (FASN) for diagnosing recurrent brain metastases, showing that 92% (11 out of 12) of patients achieved concordance with MRI as assessed by PET imaging [2][4] - The interim analysis indicated significant and selective tumor uptake in brain metastases, confirming metabolic activity compared to unclear MRI findings [3] Group 2: Market Potential and Future Plans - The CEO stated that the interim data strengthens confidence in the Phase II trial's success and lays a foundation for a pivotal study by the end of 2026, with independent assessments estimating RAD 101's U.S. market opportunity at over $500 million annually [4] - The company has achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 [4] Group 3: Regulatory Designations and Additional Trials - RAD 101 has received FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases, with over 300,000 patients diagnosed annually in the U.S. [5] - Additionally, the company secured Australian approval to initiate its First-In-Human Phase 1 clinical trial of RAD 402 for metastatic or locally advanced prostate cancer [6]