Radiopharm's RAD101 Shows 92% Success Rate in Detecting Brain Metastases—Pivotal Study Set for 2026

RAD101 Achieves 92% Concordance with MRI in Interim Phase 2b Trial

Radiopharm Theranostics (NASDAQ: RADX, ASX: RAD) revealed compelling interim data from its U.S. Phase 2b imaging trial, announcing that RAD101—a novel small-molecule PET imaging agent—matched MRI findings in 92% of the first twelve patients with suspected recurrent brain metastases. This early success marks a substantial stride toward a pivotal study launch by late 2026, according to CEO Riccardo Canevari.

Significant Clinical Potential: Addressing a $500 Million Market Opportunity

Targeting fatty acid synthase (FASN), RAD101 is designed to pinpoint cancerous brain lesions more accurately than traditional MRI alone. The press release highlights that 11 out of 12 trial participants showed significant and selective tumor uptake, reinforcing RAD101's promise for detecting challenging cases where standard imaging leaves doubt. The company cites independent research pegging the U.S. market for this technology at over $500 million annually—placing RAD101 on track to become a top-three imaging agent for brain metastases if later trials confirm the benefit.

Fast Track Designation and Path Toward Broader Adoption

With RAD101’s FDA Fast Track status, the trial is rapidly advancing. Patient enrollment has already surpassed the 50% milestone in its target group of 30 individuals, enhancing momentum. Unlike standard contrast-enhanced MRI—which can struggle to differentiate recurrence from treatment effects in follow-up scans—RAD101’s metabolic targeting may enable more precise and actionable diagnoses. Early results suggest that integrating PET-MRI using RAD101 could refine clinical decision-making for a substantial segment of patients who develop brain metastases each year.

What’s Next for Radiopharm Theranostics?

Looking ahead, Radiopharm is planning a pivotal trial launch by 2026, aiming to validate the accuracy, sensitivity, and specificity of RAD101 at a larger scale. The company's pipeline already includes multiple diagnostic and therapeutic radiopharmaceutical candidates across various solid tumors, supporting its vision as a leader in precision oncology imaging.

Takeaway for Investors and Healthcare Stakeholders

While full trial results are pending, these interim findings point to RAD101’s significant potential to transform how clinicians identify and monitor brain metastases. Investors, clinicians, and healthcare innovators will be watching closely as the program advances, especially given the strong early performance and a robust U.S. market opportunity.

Upcoming Webinar for In-Depth Discussion

To further explore the clinical implications, Radiopharm is hosting a webinar on December 16, 2025, featuring key scientific leaders behind the trial. Details and replay information can be found on Radiopharm’s website.

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