Radiopharm Hits Primary Endpoint in 92% in Interim Phase 2b Imaging Trial in Brain Metastases

 Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins, also known as the Pivalate technology.  

The interim analysis showed that 92% (11/12) of the patients treated with RAD 101 achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.

“These compelling interim data significantly strengthen confidence in the success of our Phase II trial of RAD 101 and provide a strong foundation for initiating a pivotal study by the end of 2026,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Integrating RAD 101 PET (Pivalate) with standard MRI has the potential to transform patient management and enable better treatment decisions for the more than 300,000 patients in the U.S. diagnosed with brain metastases each year. Independent commercial assessments estimate RAD 101’s U.S. market opportunity at more than $500 million annually, positioning it to become one of the top three imaging agents in the market.”

The Company recently achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 imaging in brain metastases and RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.

https://www.globenewswire.com/news-release/2025/12/15/3205269/0/en/Radiopharm-Theranostics-Achieves-Primary-Endpoint-in-92-of-Patients-at-Interim-Analysis-of-RAD-101-Phase-2b-Imaging-Trial-in-Brain-Metastases.html