GlobeNewswire·Apr 7, 2026, 7:00 AM ET

Radiopharm Theranostics and Siemens Healthineers Sign Clinical Supply Agreement for RAD101 in the U.S.

Radiopharm Theranostics & Siemens Healthineers signed a supply agreement for Siemens to radiolabel & distribute RAD101 with Fluorine-18 (18F).
RAD101 is a novel small molecule targeting fatty acid synthase (FASN) for diagnosing suspected recurrent brain metastases from solid tumors.
Interim Phase 2b trial data showed 90% concordance (18 of 20 patients) between RAD101 PET imaging & MRI, meeting the primary endpoint.
Results demonstrated significant & selective tumor uptake in brain metastases, with images confirming metabolic activity where MRI findings were equivocal.
Early follow-up & biopsy data for the first five patients indicated positive trends for sensitivity & specificity, the trial's secondary objectives.
The partnership ensures sufficient 18F-labeled RAD101 supply for the U.S. Phase 3 registrational trial following top-line data readout expected in the first half of 2026.
The product holds FDA Fast Track Designation to distinguish recurrent disease from treatment effects in brain metastases, including leptomeningeal disease.
Siemens Healthineers will utilize its U.S. national network of radiopharmacies to manufacture & distribute doses for the upcoming multi-center global Phase 3 trial.