RAD to Meet with FDA on Phase 3 Trial for RAD 101
Key points
- Scheduled FDA meeting on October 1, 2026, to discuss Phase 3 trial design
- RAD 101 Phase 2b trial showed 93% MRI concordance
- Aiming to be Phase 3 ready by year-end 2026
- Partnership with Siemens Healthineers for manufacturing and distribution
- Targeting diagnosis of brain metastases from solid tumors
Full summary
Radiopharm Theranostics Limited, a clinical-stage biopharmaceutical company, has announced an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) scheduled for October 1, 2026. The meeting aims to align on the design of a pivotal Phase 3 trial for RAD 101, a novel imaging agent targeting fatty acid synthase (FASN) for the diagnosis of recurrent brain metastases. The Phase 2b trial of RAD 101 demonstrated 93% concordance with MRI, meeting the primary endpoint. The company plans to be Phase 3 ready by year-end 2026, with a partnership with Siemens Healthineers for manufacturing and distribution.
Outlook
The company expects to finalize the Phase 3 trial design post the FDA meeting, aiming to be Phase 3 ready by year-end 2026.
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