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Radiopharm Theranostics Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Update summary15 Dec, 2025
Study background and rationale
Fatty acid synthase is crucial for brain cancer cell survival, enabling growth in a lipid-deprived environment and supporting resistance to therapies.
Brain metastases mainly originate from lung, breast, and melanoma, accounting for 90% of cases, with poor overall survival.
Differentiating between tumor recurrence and treatment effects post-stereotactic radiosurgery is challenging with MRI alone.
Study design and progress
The first-in-class Phase IIb U.S. study is ongoing, enrolling patients with equivocal MRI findings after radiosurgery.
The Phase 2b trial is a U.S. multi-center, open-label, single-arm study with 30 participants.
Previous Phase IIa (22 patients) showed high tracer uptake in brain metastases, independent of tumor origin.
The trial has reached 50% patient enrollment and received FDA Fast Track Designation.
Phase IIb interim analysis is positive, with a final readout expected in the first half of 2026; Phase III (150 patients) is planned.
Interim analysis results and key findings
92% of evaluable patients in the Phase 2b trial achieved concordance with MRI, meeting the primary endpoint.
Significant and selective tumor uptake was observed in suspected or recurrent brain metastases.
PET imaging with RAD101 confirmed metabolic activity in brain metastases, even with equivocal MRI findings.
High PET SUV (>2) correlates with shorter survival, while MRI contrast enhancement is less informative.
PET imaging provides quantifiable data (SUV max) that can monitor tumor progression and guide early treatment decisions.
How does RAD 101 address CE-MRI limitations?
RAD 101's OS prediction potential?
Fast Track impact on pivotal study timeline?
What is RAD-101's unique market position
How does RAD-101 enable earlier patient intervention
What is the truth standard for phase 3 approval
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Next Radiopharm Theranostics earnings date
Q2 202626 Feb, 2026
Next Radiopharm Theranostics earnings date
Q2 202626 Feb, 2026
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Frequently asked questions
Radiopharm Theranostics Limited is a biotechnology company focused on the development of radiopharmaceutical products for the diagnosis and treatment of cancer. The company specializes in theranostics, combining therapeutic and diagnostic capabilities into a single platform. Its pipeline includes targeted radiopharmaceuticals designed to deliver precision treatments while enabling imaging for monitoring disease progression. The company is headquartered in Melbourne, Australia, and its shares are listed on the ASX.
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