RAD Announces Positive Phase 2b Trial Results of RAD 101
Key points
- RAD 101 PET demonstrated 93% concordance with MRI in brain metastases diagnosis
- Preliminary data shows 86% sensitivity in detecting brain metastases
- Plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026
Full summary
Radiopharm Theranostics announced positive results from the Phase 2b trial of RAD 101, a novel imaging agent targeting fatty acid synthase (FASN) for diagnosing brain metastases. The trial showed 93% concordance between PET imaging and MRI in diagnosing brain metastases, meeting the primary endpoint. Preliminary data from 14 patients showed 86% sensitivity, indicating RAD 101's potential to accurately identify brain metastases. The company plans to advance RAD 101 into a U.S. Phase 3 pivotal trial in Q4 2026. RAD 101 has received FDA Fast Track Designation and a partnership with Siemens Healthineers for manufacturing and distribution.
Outlook
The positive trial results provide a strong foundation for the upcoming pivotal trial, with the potential to bring a more precise diagnostic tool to patients and clinicians.
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