Radiopharm Completes Phase 2b Enrollment, Reports 90% MRI Concordance
Radiopharm Theranostics has dosed the final patient in its 30-patient U.S. Phase 2b imaging trial of RAD 101, achieving 90% concordance with MRI for detecting recurrent brain metastases. The company expects primary endpoint readout in June 2026 and plans to launch a U.S. Phase 3 pivotal trial thereafter.
1. Phase 2b Imaging Trial Enrollment Completed
Radiopharm Theranostics has dosed the final patient in its open-label, single-arm Phase 2b trial of 18F-RAD101 across 30 individuals with confirmed recurrent brain metastases from solid tumors. The multicenter U.S. trial is evaluating the diagnostic performance of RAD 101 compared with conventional MRI.
2. Interim Data Demonstrates 90% Concordance with MRI
Interim analysis shows RAD 101 achieved 90% concordance with contrast-enhanced MRI, meeting the study’s primary endpoint for lesion detection. Full data readout is scheduled for June 2026, providing a critical assessment of RAD 101’s diagnostic accuracy.
3. Advancement to Phase 3 and FDA Engagement
Following Phase 2b completion, Radiopharm plans to initiate a U.S. pivotal Phase 3 trial and engage the FDA to define the optimal regulatory pathway. RAD 101 holds Fast Track designation for distinguishing recurrent disease from treatment effects in brain metastases.