GlobeNewswire·Sep 14, 2026, 8:00 AM ET

Radiopharm Theranostics Selected for Late-Breaking Oral Presentation of Positive Data from Interim Analysis of U.S. Phase 2b Imaging Trial of RAD101 at 2026 Society of Neuro-Oncology Annual Meeting

RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2b trial primary endpoint
An FDA meeting is scheduled for October 1st to align on the RAD101 Phase 3 pivotal trial protocol
The Brain Metastases Imaging market has a total addressable market of approximately $600 million with no currently approved PET products
RAD101 is a novel FASN-targeting small molecule radiolabeled with Fluorine-18 for diagnosing suspected recurrent brain metastases from solid tumors
Positive interim data from the Phase 2b trial will be presented as a late-breaking oral at the SNO26 conference in Philadelphia
Preliminary 86% sensitivity was observed in 14 patients with six-month follow-up or biopsy data
RAD101 received FDA Fast Track Designation to distinguish recurrent disease from treatment effects
A partnership with Siemens Healthineers will support manufacturing & distribution of 18F-labeled RAD101 for the upcoming Phase 3 U.S. trial
The Phase 2b study assessed diagnostic performance in 30 evaluable individuals with suspected recurrent brain metastases after stereotactic radiosurgery
RAD101 selectively binds to fatty acid synthase (FASN), which is overexpressed in cerebral metastases from solid tumors