RADX · Radiopharm Theranostics Limited

Radiopharm Theranostics announced the completion of enrollment and dosing of the final patient in its U.S. Phase 2b imaging trial for RAD 101, a novel imaging small molecule targeting fatty acid synthase (FASN). The trial enrolled 30 individuals with confirmed recurrent brain metastases from solid tumors. Interim data demonstrated 90% concordance with MRI, the study's primary endpoint, reinforcing the asset's potential to address limitations of contrast-enhanced MRI in follow-up surveillance. The company expects the full clinical trial readout for the primary endpoint in June 2026. Management stated plans to advance RAD 101 into a U.S. Phase 3 pivotal trial and engage with the FDA to define the regulatory pathway. RAD 101 holds FDA Fast Track Designation for distinguishing recurrent disease from treatment effect in brain metastases, highlighting its potential to meet an unmet medical need in a patient population exceeding 300,000 annually in the U.S.