Radiopharm Theranostics aligns with US FDA on trial design

Radiopharm Theranostics (ASX:RAD) reached an agreement with the US Food and Drug Administration on the design of a single pivotal Phase 3 imaging trial for its RAD101 diagnostic molecule.

The agreement follows an End-of-Phase 2 meeting and receipt of final meeting minutes regarding the evaluation of brain metastases in patients after radiotherapy.

“Accurately distinguishing recurrent tumour from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases,” said Radiopharm Theranostics CEO Riccardo Canevari.

The Phase 3 trial will enrol roughly 280 patients with indeterminate brain metastases across multiple centres to assess sensitivity and specificity thresholds.

The company stated that CRO selection is scheduled for completion in the fourth quarter of 2026, with site activations and patient dosing planned for the first half of 2027.

Following the announcement, the Radiopharm Theranostics share price was up at $0.0030.

The business is preparing clinical supply of 18F-labelled RAD101 through an established commercial manufacturing partnership with Siemens Healthineers.

RAD101 is designed to selectively bind fatty acid synthase to improve cancer detection in the central nervous system following Phase 2b trial data showing 93% concordance with MRI scans.