Radiopharm completes End-of-Phase 2 FDA meeting for brain metastases imaging agent RAD101
The company said the meeting outlined a path to pivotal development, with formal FDA meeting minutes expected within about 30 days and Phase 3 readiness work already underway.
Radiopharm Theranostics Limited announced on October 5, 2026 that it had completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding RAD101, the company's investigational radiopharmaceutical imaging agent for the detection of brain metastases1.
RAD101 is described as the company's novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors1. The company pointed to earlier trial results, noting that previously reported data from the Phase 2b clinical trial showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial's primary endpoint1.
Radiopharm said it expects to receive the FDA's official meeting minutes within approximately 30 days, which will provide the formal record of the meeting and the Agency's feedback on the proposed pivotal clinical development program1, and said it intends to provide a further update following receipt and review of the official minutes1.
In the meantime, the company said it is moving immediately to advance Phase 3 readiness activities, including clinical and operational planning, so the program is positioned to progress efficiently once the Agency's formal feedback is received1.
The release also noted regulatory and manufacturing context: RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease1, and the company recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm's upcoming Phase 3 registrational trial in the U.S.1
Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX)1, and describes itself as a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need1. The company cautioned that RAD101 is an investigational product and has not been approved for commercial use by the FDA or any other regulatory authority1.
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