Core Insights - Radiopharm Theranostics is advancing its clinical programs with promising early data from multiple trials, indicating strong potential for its radiopharmaceutical pipeline [1][2][3] Clinical Trials and Data - Preliminary data from the Phase 2b trial of RAD 101 shows uptake in brain metastases from solid tumors, with topline results expected by H1 2026 [1][6] - The Phase 1 trial of RAD 202 (HER2) has shown higher than expected tumor uptake, with data from the second cohort anticipated by year-end 2025 [1][10] - RAD 204 (PD-L1) has demonstrated promising tumor uptake and stable disease in two out of three patients at the first dose level [5][11] - RAD 301 is being evaluated in a Phase 1 imaging trial for pancreatic cancer, with initial data supporting a move to a Phase 2 trial [8][12] Regulatory and Designation Updates - RAD 101 has received FDA Fast Track Designation to expedite its review process for patients with cerebral metastases [3] - RAD 301 has received Orphan Drug Designation from the FDA, highlighting its potential in treating pancreatic ductal adenocarcinoma [8] Company Strategy and Future Plans - The company plans to initiate Phase 1 trials for RV01 and RAD402 by year-end 2025, expanding its clinical portfolio to include four therapeutic candidates and two imaging agents [2] - The strategic execution of the company remains strong, with a focus on advancing multiple trials and achieving significant milestones [2][9]

ITM's n.c.a. Lu is a market-approved, highly pure form of the beta-emitting radioisotope, Lutetium-177, that can be linked to tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. Lu and has marketing authorization in the EU (brand name EndolucinBeta). "Ensuring supply of key isotopes continu ...