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Highlights
- Radiopharm Theranostics has signed a clinical supply agreement with Siemens Healthineers for RAD101 in the U.S.
- Interim Phase 2b data reported 90% concordance with MRI scans, meeting the primary endpoint.
- The agreement supports supply for an upcoming global Phase 3 registrational trial.
- RAD101 demonstrated tumour uptake and improved clarity over equivocal MRI findings.
- The program holds FDA Fast Track status for diagnosing recurrent brain metastases.
Radiopharm Theranostics (ASX:RAD) has entered into a clinical supply agreement with Siemens Healthineers to support the development of its imaging candidate RAD101 in the United States. The company has also released updates from its ongoing Phase 2b trial of RAD 101.
Agreement to Support Phase 3 Trial Supply
The agreement outlines that Siemens Healthineers will radiolabel RAD101 with Fluorine-18 and manage its distribution across the United States. The arrangement is intended to ensure the supply of 18F-labeled RAD101 in the U.S ahead of RAD’s planned multi-center global Phase 3 registrational trial.
Interim Trial Data Shows High Concordance with MRI
The data reported from the interim analysis in the Phase 2b trial, indicated that RAD101 demonstrated selective and considerable tumour uptake in brain metastases. The analysis showed a 90% concordance rate with MRI scans, meeting the study’s primary endpoint. Imaging results also confirmed metabolic activity, compared to equivocal MRI findings, while early follow-up data showed positive trends for diagnostic sensitivity and specificity.
Focus on Brain Metastases Diagnosis
RAD101, radiolabelled with Fluorine-18, targets fatty acid synthase (FASN) to help identify suspected recurrent brain metastases from various solid tumors. The program has received Fast Track designation from the U.S. Food and Drug Administration, highlighting its potential to differentiate between disease recurrence and treatment effects.
RAD shares were trading at AUD 0.02 per share at the time of writing on 7 April 2026.
