- Business
- Radiopharm Theranostics Limited (ASX:RAD; NASDAQ:RADX), a clinical-stage radiotherapeutics company, develops innovative radiopharmaceutical products for diagnostic and therapeutic applications targeting cancer indications with high unmet medical needs, including solid tumors such as non-small cell lung cancer, breast cancer, pancreatic cancer, brain metastases, and prostate cancer. The company's pipeline features therapeutic candidates RAD204, a PD-L1-targeted nanobody radiolabeled with Lutetium-177 in Phase 1 for PD-L1-positive solid tumors; RAD202, a HER2-targeted nanobody radiolabeled with Lutetium-177 in Phase 1 for HER2-positive solid tumors; and RV-01, a B7-H3-targeted monoclonal antibody radiolabeled with Lutetium-177 advancing toward Phase 1/2a through a joint venture with MD Anderson Cancer Center; alongside diagnostic agents RAD101, a short chain fatty acid small molecule radiolabeled with Fluorine-18 in Phase 2b for brain metastases, and RAD301, an integrin αvβ6-targeted peptide radiolabeled with Gallium-68 in Phase 1 for pancreatic cancer, with preclinical programs RAD402 (KLK3-targeted monoclonal antibody with Terbium-161 for prostate cancer) and RAD302 (integrin αvβ6-targeted peptide therapeutic with Lutetium-177). Founded in 2021 and headquartered in Carlton, Australia, Radiopharm operates globally with clinical trials in the United States and Australia, supported by subsidiaries including Radiopharm Theranostics (USA), Inc. Recent developments include a A$35 million capital raise in October 2025 to fund clinical trials and extend cash runway into 2027; FDA Fast Track Designation for RAD101 in June 2025 and Investigational New Drug clearance for RV-01 in July 2025; Dose Safety Monitoring Committee approval in May 2025 to escalate dosing in RAD204's Phase 1 trial; first patient dosing in RAD202's Phase 1 HEAT trial in June 2025; supply agreements with ITM Isotope Technologies Munich SE for non-carrier-added Lutetium-177 and Cyclotek for Terbium-161 doses; and dual-listing on NASDAQ as RADX in 2024.