Radiopharm Theranostics and Siemens Healthineers signed a clinical supply agreement for RAD101, ensuring supply for the upcoming U.S. Phase 3 trial following positive interim Phase 2b data showing 90% concordance with MRI.
Key takeaways
Radiopharm signed a supply agreement with Siemens Healthineers for the radiolabeling and distribution of RAD101 in the U.S.
Interim Phase 2b trial data for RAD101 showed 90% concordance with MRI, meeting the primary endpoint.
The agreement ensures supply for a planned multi-center global Phase 3 registrational trial in the U.S.
RAD101 has received U.S. FDA Fast Track Designation for distinguishing recurrent disease from treatment effect in brain metastases.
Topline data from the Phase 2b trial is expected in the first half of 2026.