Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.
- RAD101 shows 90% concordance with MRI in Phase 2b interim analysis
- Siemens Healthineers to supply Fluorine-18 labelled RAD101 for U.S. Phase 3 trial
- FDA grants Fast Track Designation for RAD101 in brain metastases diagnosis
- Partnership supports global multi-centre Phase 3 registrational trial
- RAD101 targets fatty acid synthase for improved diagnostic precision
Clinical Supply Agreement Signed
Radiopharm Theranostics (ASX:RAD) has entered into a clinical supply agreement with Siemens Healthineers to radiolabel and distribute RAD101, a novel Fluorine-18 (18F) labelled imaging agent. The agreement is intended to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S., marking a key step in the development of RAD101 for diagnosing suspected recurrent brain metastases from solid tumours.
Promising Interim Phase 2b Data
The announcement follows an interim analysis from the ongoing Phase 2b trial, which showed 90% concordance between RAD101 PET imaging and MRI in 20 patients, meeting the primary endpoint. The data indicated significant and selective tumour uptake in brain metastases, with images demonstrating metabolic activity in lesions that were equivocal on MRI. Early follow-up and biopsy data from a subset of patients also suggested positive trends in sensitivity and specificity, which are secondary objectives of the trial.
FDA Fast Track Designation and Trial Progression
RAD101 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) to facilitate its development for distinguishing recurrent disease from treatment effects in brain metastases, including leptomeningeal disease. The supply agreement with Siemens Healthineers is intended to ensure sufficient availability of the radiolabelled compound as Radiopharm prepares to initiate a multi-centre global Phase 3 trial following topline data readout expected in the first half of 2026.
Strategic Partnership with Siemens Healthineers
Siemens Healthineers will leverage its extensive U.S. radiopharmacy network to manufacture and distribute RAD101. Barry Scott, Head of Radiopharma at Siemens Healthineers, highlighted the company’s capabilities in delivering PET imaging solutions for challenging conditions such as brain metastases, which affect over 300,000 people annually in the U.S.
Radiopharm’s Broader Clinical Pipeline
Radiopharm Theranostics is a clinical-stage biopharmaceutical company developing radiopharmaceuticals across peptides, small molecules, and monoclonal antibodies for cancer diagnostics and therapeutics. Its clinical program includes one Phase 2 and five Phase 1 trials targeting various solid tumours, including lung, breast, and brain metastases. The company recently reported a 44% increase in net loss for the half-year ended December 2025, reflecting expanded R&D investment, alongside a $35 million capital raise to support its pipeline advancement. Earlier coverage detailed the promising Phase 2b results for RAD101 and the initiation of a Phase 1 trial for RAD402 in advanced prostate cancer, indicating ongoing clinical momentum for Radiopharm’s portfolio.
Bottom Line?
The Siemens Healthineers partnership secures RAD101 supply for a pivotal Phase 3 trial, but clinical and regulatory outcomes remain to be seen.
Questions in the middle?
- How will the Phase 3 trial data compare with the promising interim Phase 2b results for RAD101?
- What are the commercial implications if RAD101 receives regulatory approval for brain metastases diagnosis?
- How might Radiopharm’s broader pipeline progress alongside RAD101’s development?