Highlights

  • RAD101 Phase 2b imaging trial data demonstrated 93% concordance between PET imaging and MRI across evaluable lesions.
  • RAD101 data was selected for a late-breaking oral presentation at the 2026 Society of Neuro-Oncology Annual Meeting.
  • Radiopharm plans discussions with the FDA regarding the RAD101 Phase 3 pivotal trial protocol.
  • The company continues developing radiopharmaceutical diagnostic and therapeutic programs across oncology indications.

Radiopharm Theranostics Limited (ASX:RAD) is a clinical-stage radiotherapeutics company developing radiopharmaceutical products for diagnostic and therapeutic applications in oncology. The company’s pipeline includes peptide, small molecule and monoclonal antibody technologies targeting areas of high unmet medical need. Recent progress has centred on RAD101, a small molecule imaging agent being evaluated for detection of suspected recurrent brain metastases from solid tumours.

RAD101 Phase 2b Trial Advances Brain Metastases Imaging Program

Radiopharm reported positive interim analysis results from its U.S. Phase 2b imaging trial of 18F-RAD101 in participants with suspected recurrent brain metastases from solid tumours.

The trial data showed 93% concordance between RAD101 PET imaging and MRI across all evaluable lesions, meeting the study’s primary endpoint. The results also demonstrated selective tumour uptake of RAD101, including cases where PET imaging provided metabolic information alongside equivocal MRI findings.

The Phase 2b study is evaluating RAD101’s diagnostic performance in patients with suspected recurrent brain metastases following previous treatment. The primary objective is assessing concordance between RAD101 PET-positive lesions and lesions identified through conventional imaging methods.

Secondary objectives include evaluating sensitivity and specificity in distinguishing tumour recurrence from radiation-associated changes.

Radiopharm stated that the Phase 2b data will support preparation for a planned multi-centre, global Phase 3 imaging trial.

RAD101 Technology and Clinical Development Pathway

RAD101 is a novel imaging small molecule targeting fatty acid synthase (FASN), a multi-enzyme protein involved in fatty acid synthesis that is overexpressed in cerebral metastases from solid tumours.

The compound is radiolabelled with Fluorine-18 and is being developed as a diagnostic imaging agent for suspected recurrent brain metastases.

Radiopharm has received U.S. Food and Drug Administration Fast Track Designation for RAD101 to support development in distinguishing recurrent disease from treatment effects in brain metastases.

The company also announced a Partnership with Siemens Healthineers, under which Siemens Healthineers will manufacture and distribute doses of 18F-labelled RAD101 to support the upcoming Phase 3 pivotal trial in the United States.

Previous Phase 2a imaging trial results from Imperial College London showed significant tumour uptake in patients with brain metastases, including both pre-treated and treatment-naïve patients.

Radiopharm continues evaluating RAD101 as part of its broader radiopharmaceutical platform designed for cancer imaging applications.

Radiopharm Oncology Pipeline and Future Focus

Radiopharm is developing a portfolio of radiopharmaceutical products across diagnostic and therapeutic applications in oncology.

The company’s clinical programs include RAD101 alongside additional early-stage programs targeting solid tumours including lung, breast, prostate and brain cancers.

The brain metastases imaging opportunity represents a significant clinical area where current imaging approaches can face challenges in differentiating active disease from treatment effects.

Radiopharm reported that more than 300,000 patients in the United States are diagnosed annually with cerebral metastases. The company is focused on advancing RAD101 through further clinical development while continuing to build its broader radiopharmaceutical pipeline.

The company’s upcoming activities include discussions with the FDA regarding the Phase 3 trial protocol and continued preparation for future clinical development milestones.

Radiopharm also continues maintaining its listings on the ASX and Nasdaq as it progresses its oncology-focused platform.

Key Insights

Radiopharm Theranostics is advancing its radiopharmaceutical imaging platform through RAD101 clinical development. The Phase 2b imaging trial reported positive interim findings, supporting continued regulatory engagement and preparation for a planned Phase 3 imaging study in brain metastases.