Radiopharm Theranostics Eyes Pivotal Trial Path After Encouraging Interim Results

Radiopharm Theranostics (NASDAQ:RADX) shares are down during Tuesday’s trading session following the company’s announcement of promising interim results from its Phase 2b clinical trial for RAD 101. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. Phase 2b Interim Data Shows 90% MRI Concordance The second interim analysis revealed that 90% of patients dosed with RAD 101 achieved concordance with MRI imaging, meeting the primary endpoint of the trial. The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. Early Six-Month Follow-Up Signals Strengthen Diagnostic Metrics Additionally, the first five patients with available data from a six-month follow-up showed a positive trend for sensitivity and specificity, which are critical metrics for diagnostic tests. In the U.S., RAD 101 has received FDA Fast Track Designation, aimed at distinguishing between recurrent disease and treatment effects in brain metastases. The company plans to host a webinar on March 25 to discuss these findings further, with final data expected by June, which will guide the next steps towards a pivotal trial. Radiopharm Theranostics Management Commentary “The strength and consistency of these interim results further validate the potential of RAD 101 to address one of the most challenging diagnostic gaps in neuro-oncology,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “With 90% concordance demonstrated to date and encouraging early signals in sensitivity and specificity, we are increasingly confident in RAD 101’s ability to support more accurate and timely treatment decisions for patients with brain metastases. We look forward to the final data readout from the full 30-patient study by June, which will guide our path toward a pivotal trial,” Canevari added. Radiopharm Theranostics shared interim data from the first twelve patients in its U.S. Phase 2b imaging trial of RAD 101 in brain metastases. The interim analysis released in December 2025 showed that 92% (11/12) of the patients treated with RAD 101 achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. RADX Stock Price Activity: Radiopharm Theranostics shares were down 3.23% at $4.48 at the time of publication on Tuesday, according to Benzinga Pro data. Image via Shutterstock