Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) announced a clinical supply agreement with Siemens Healthineers for the manufacturing and distribution of RAD101 in the United States. The partnership will support Radiopharm's upcoming Phase 3 registrational trial for the brain metastases imaging agent.

RAD101 is a novel imaging small molecule targeting fatty acid synthase radiolabeled with Fluorine-18 for diagnosing suspected recurrent brain metastases from solid tumors. The compound has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effects of brain metastases.

Interim analysis data from Radiopharm's Phase 2b trial showed that 90% of patients achieved concordance between PET imaging and MRI, meeting the primary endpoint. The analysis included 20 patients and demonstrated selective tumor uptake in brain metastases.

"The second interim analysis showed 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI," said Riccardo Canevari, CEO of Radiopharm Theranostics. The company expects to report topline data from the Phase 2b trial in the first half of 2026.

Under the agreement, Siemens Healthineers will radiolabel and distribute RAD101 with Fluorine-18 to clinical sites participating in the Phase 3 trial. Siemens operates a network of radiopharmacies across the United States.

Brain metastases affect more than 300,000 people annually in the United States, according to the company statement. Radiopharm's clinical program includes one Phase 2 and five Phase 1 trials across various solid tumor cancers including lung, breast, and brain metastases.