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Radiopharm completes productive End-of-Phase 2 FDA meeting for RAD101 brain metastases imaging agent
RADXRadiopharm Theranostics Ltd
Radiopharm Theranostics completed a constructive End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding RAD101, an investigational Fluorine-18-labeled imaging agent targeting fatty acid synthase for detecting recurrent brain metastases. The interaction provided a clear framework for the pivotal clinical development plan in brain metastases imaging. The company is advancing Phase 3 readiness activities and expects to receive official FDA meeting minutes within approximately 30 days. RAD101 previously demonstrated 93% concordance with MRI in Phase 2b trials and holds Fast Track Designation. Radiopharm Theranostics is a clinical-stage radiopharmaceutical company developing diagnostic and therapeutic products for cancer.