Clinical TrialJul 22, 2026, 07:01 AM
Radiopharm RAD101 Phase 2b Brain Metastases Trial Meets Primary Endpoint
AI Summary
Radiopharm Theranostics announced positive data from its Phase 2b trial of RAD101 for suspected recurrent brain metastases, meeting the primary endpoint with 93% concordance with MRI. The trial also showed preliminary 86% sensitivity in a subset of patients. Based on these results, the company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026, targeting a ~$600+ million market. RAD101 has already received U.S. FDA Fast Track Designation and has a manufacturing and distribution partnership with Siemens Healthineers.
Key Highlights
- RAD101 Phase 2b trial met its primary endpoint for brain metastases.
- Demonstrated 93% concordance with MRI across all evaluable lesions.
- Preliminary 86% sensitivity in 14 patients with 6-month follow-up/biopsy.
- Company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026.
- Imaging Brain Metastases total addressable market is estimated at ~$600+ million.
- RAD101 received U.S. FDA Fast Track Designation.
- Partnership with Siemens Healthineers for manufacturing and distribution of 18F-labeled RAD101.
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