Radiopharm Theranostics Announces Alignment with U.S. FDA on Single Pivotal Phase 3 Trial for RAD101 in Diagnosis of Brain Metastases

Radiopharm Theranostics received FDA alignment on a pivotal Phase 3 trial design for RAD101, a novel imaging agent for detecting brain metastases. The single multicenter trial will enroll approximately 280 patients and is substantially smaller than historical imaging studies, reflecting significant unmet medical need. The company expects to initiate the trial in the first half of 2027 with manufacturing support from Siemens Healthineers.