Radiopharm secures FDA backing for a single pivotal trial of brain metastases imaging agent

Radiopharm Theranostics obtained FDA agreement for a single pivotal Phase 3 trial of RAD101, an imaging agent for brain metastases, allowing a smaller trial with about 280 patients compared to historical programs. The agent targets fatty acid synthase to improve accuracy detecting brain metastases and has FDA Fast Track Designation, with plans to start dosing in 2027.

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