Radiopharm Theranostics To Meet FDA On Phase 3 Design For RAD101; Phase 2b Shows 93% MRI Concordance
Radiopharm Theranostics (RADX) said it will hold an End-of-Phase 2 meeting with the FDA on Oct. 1, 2026 to align on pivotal Phase 3 trial design for RAD101 in suspected recurrent brain metastases after radiotherapy. The company cited Phase 2b results showing 93% MRI concordance and selective tumor uptake. RAD101 has Fast Track status and Siemens will manufacture and distribute it for a planned Phase 3 starting Q4 2026.


