Radiopharm RAD101 achieves 93% imaging concordance

• Radiopharm Theranostics (NASDAQ:RADX) reported RAD101 PET achieved 93% concordance with MRI across evaluable lesions, meeting the Phase 2b trial’s primary endpoint.
• Preliminary follow-up and biopsy data from 14 evaluable patients showed 86% sensitivity for detecting disease.
• Radiopharm plans an FDA meeting on October 1, 2026, to discuss its pivotal Phase 3 protocol and will present the Phase 2b data at SNO26 in November.

Radiopharm Theranostics (NASDAQ:RADX) reported that RAD101 PET achieved 93% concordance with MRI across all evaluable lesions in an interim Phase 2b analysis, meeting the imaging trial’s primary endpoint.

The study evaluates Fluorine-18-labelled RAD101 in patients with suspected recurrent brain metastases from solid tumors, with the imaging agent designed to target fatty acid synthase, or FASN.

Radiopharm also reported substantial and selective tumor uptake, while preliminary six-month follow-up or biopsy data from 14 evaluable patients showed 86% sensitivity, a secondary trial objective.

The Phase 2b findings were selected for a late-breaking oral presentation at the Society for Neuro-Oncology Annual Meeting in Philadelphia, scheduled for November 12-15, 2026.

Radiopharm plans to meet with the FDA on October 1 to align on the protocol for a global multicenter Phase 3 pivotal imaging trial, with RAD101 already holding FDA Fast Track designation for distinguishing recurrent brain metastases from treatment effects.

The company estimates a roughly $600 million total addressable market for brain metastases imaging and said Siemens Healthineers will manufacture and distribute 18F-labelled RAD101 doses to support the planned U.S. Phase 3 study.