RAD101 PET demonstrated 93% concordance with MRI across all evaluable lesions, meeting the trial's primary endpoint

Meeting with FDA planned on October 1st to align on RAD101Phase 3 pivotal trial protocol

Brain Metastases Imaging has ~$600 million total addressable market, and there are no currently approved PET products

SYDNEY, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, NASDAQ:RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that positive data from an interim analysis of the Company’s Phase 2b imaging clinical trial (NCT06777433) of 18F-RAD101 (RAD101) in participants with suspected recurrent brain metastases from solid tumors has been selected for a late-breaking oral presentation at the  31st Annual Meeting of the Society of Neuro-Oncology (SNO26), taking place from November 12-15, 2026 in Philadelphia.

RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.