Radiopharm's RAD 101 Hits 92% Concordance in Phase 2b Interim: Strong Early Results Point to Major Market Potential

92% Concordance Achieved: RAD 101 PET Imaging Aligns with MRI in Brain Metastases Patients

Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX) delivered a notable milestone, announcing interim data from its U.S. Phase 2b trial for RAD 101, its innovative PET imaging agent. Out of twelve brain metastases patients evaluated so far, eleven (92%) showed concordance between PET images using RAD 101 and conventional MRI results. This high agreement strengthens confidence in the trial and highlights the imaging agent’s ability to detect and characterize recurrent brain tumors—even where MRI results were unclear.

Strong Clinical Validation and Differentiated Approach

RAD 101 is a small-molecule PET tracer radiolabelled with Fluorine-18, specifically designed to target fatty acid synthase (FASN)—a protein highly expressed in various solid tumors, including cerebral metastases. Notably, significant and selective tumor uptake was observed in patient scans, with the PET images often clarifying ambiguous MRI findings. The Phase 2b interim analysis reinforces data from prior studies, where RAD 101 uptake was robust regardless of tumor origin, positioning the agent as a potential breakthrough in brain cancer diagnostics.

Potential Market Impact: Over $500 Million Opportunity in the U.S. Alone

The company estimates a U.S. addressable market of over $500 million annually for RAD 101, citing more than 300,000 patients diagnosed with cerebral metastases each year. Current imaging, such as contrast-enhanced MRI, often struggles to differentiate between recurrent tumor tissue and treatment effects after therapies like stereotactic radiosurgery (SRS). RAD 101 could help fill this diagnostic gap—particularly with its FDA Fast Track Designation to assess recurrent disease versus radiation-induced changes.

Next Steps: Advancing to Pivotal Trials by End of 2026

With 50% enrollment already achieved in the current Phase 2b trial and FDA Fast Track Designation secured, Radiopharm is eyeing a pivotal registration study as soon as late 2026. CEO Riccardo Canevari emphasized that the data "provide a strong foundation" for broader studies, with the potential to reshape treatment pathways for a large population of cancer patients with brain metastases. The upcoming webinar on December 15 (U.S.)/December 16 (Australia) will give investors and clinicians deeper insight into the latest trial data and development strategy.

Key Takeaway: Compelling Early Evidence and Commercial Promise

The 92% concordance in the Phase 2b interim readout suggests RAD 101 could offer clinicians greater confidence in diagnosing recurrent brain tumors—especially where MRI results are inconclusive. The data bolsters Radiopharm's vision of moving from strong interim evidence to pivotal trials and potential commercial adoption, with the addressable market and clinical demand both substantial. Investors and practitioners should follow forthcoming results and regulatory updates, as these could have meaningful implications for the management of brain metastases in oncology care.

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