GlobeNewswire·Aug 17, 2026, 7:30 AM ET

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

RAD 101 Phase 2b trial achieved 93% concordance with MRI across all evaluable lesions, meeting the primary endpoint.
An End-of-Phase 2 meeting with the U.S. FDA is scheduled for October 1, 2026, to align on pivotal Phase 3 trial design.
The company remains on track to be Phase 3-ready by the end of 2026.
RAD 101 is a novel Fluorine-18-labeled small-molecule imaging agent targeting fatty acid synthase (FASN) to diagnose recurrent brain metastases.
The product has received FDA Fast Track Designation to distinguish between recurrent disease & treatment effects in brain metastases.
A partnership with Siemens Healthineers has been established for the manufacture & distribution of 18F-labeled RAD101 doses for the upcoming Phase 3 trial.
The Phase 2b data showed substantial tumor uptake of RAD101, confirming metabolic activity in PET imaging where MRI findings were equivocal.