RAD101

July 22, 2026: Radiopharm Theranostics (ASX: RAD; NASDAQ: RADX) reported positive results from a U.S. multicenter, open-label, single-arm Phase 2b trial of 18F-RAD101, an FASN-targeted PET imaging agent, in 30 evaluable participants with suspected recurrence of brain metastases after stereotactic radiosurgery/radiotherapy. The primary endpoint was met: imaging analysis showed 93% concordance between RAD101 PET and MRI across all assessed lesions. In a subset of 14 patients with evaluable six-month follow-up and/or biopsy data, preliminary sensitivity was 86% (12/14); specificity is expected in Q4 2026.

RAD101 has FDA Fast Track Designation for distinguishing recurrent disease from treatment effect in brain metastases (including leptomeningeal disease). The company plans to advance RAD101 into a U.S. pivotal Phase 3 imaging trial in Q4 2026 and said the Phase 2b dataset will support initiation of a global, multicenter Phase 3 program. Radiopharm also noted a partnership with Siemens Healthineers to manufacture and distribute 18F-RAD101 doses for the upcoming Phase 3 trial.