Radiopharm Theranostics reports 93% trial success
- Radiopharm Theranostics reported positive Phase 2b trial results showing 93% image concordance for its brain cancer imaging agent.
- The company targets a US$600+ million imaging market where no approved PET products currently exist.
- Trial data will support launching a global Phase 3 pivotal imaging trial in late 2026.
Radiopharm Theranostics (ASX:RAD) announced positive Phase 2b trial results showing 93% concordance between MRI and PET imaging for its RAD 101 diagnostic candidate in 30 brain metastasis patients.
The imaging study met its primary trial endpoint while addressing an Australian biopharmaceutical sector focused on brain metastasis diagnostics.
"The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology," said Radiopharm Theranostics CEO and Managing Director Riccardo Canevari.
Secondary objective data from 14 follow-up patients demonstrated 86% preliminary sensitivity, with full specificity figures scheduled for release in the fourth quarter of 2026.
The company plans to initiate a pivotal multi-centre Phase 3 trial in the United States during the fourth quarter of 2026. Following the announcement, the Radiopharm Theranostics share price was unchanged at $0.02.
The imaging candidate uses Fluorine-18 radiolabelling to target fatty acid synthase in recurring brain tumours.
The business is targeting a total addressable market exceeding US$600 million across the United States, where over 300,000 patients are diagnosed with cerebral metastases each year.
