Radiopharm Theranostics and Siemens Healthineers Sign Clinical Supply Agreement for RAD101 Phase 3 Trial

On April 7, 2026, Radiopharm Theranostics announced a clinical supply agreement with Siemens Healthineers for the manufacturing and distribution of RAD101 in the United States. RAD101 is a novel 18F-labeled small molecule targeting fatty acid synthase (FASN) for the imaging and diagnosis of recurrent brain metastases. Under the agreement, Siemens Healthineers will leverage its national radiopharmacy network to provide 18F-labeled RAD101 for Radiopharm’s upcoming multi-center global Phase 3 registrational trial. The company also provided a clinical update, noting that a second interim analysis of the Phase 2b trial showed a 90% concordance (18/20 patients) between RAD101 PET imaging and MRI, meeting the primary endpoint. The data demonstrated significant and selective tumor uptake in brain metastases. Radiopharm has previously received FDA Fast Track Designation for RAD101. Topline data from the Phase 2b trial is expected in the first half of 2026, which will precede the initiation of the Phase 3 study supported by this supply partnership.