Radiopharm Theranostics disclosed that 11 of the first 12 patients enrolled in its U.S. Phase 2b imaging trial of RAD 101 achieved the primary endpoint, with a 92 % concordance rate with MRI. The interim analysis, released on December 15, 2025, showed selective tumor uptake in brain metastases and confirmed metabolic activity in lesions that were equivocal on MRI.
The data reinforce the company’s strategy to provide a PET imaging agent that can distinguish recurrent tumor from treatment effect in patients with solid‑tumor brain metastases. With an estimated U.S. market opportunity of more than $500 million annually and over 300 000 patients diagnosed each year, RAD 101 could become a key diagnostic tool in a high‑need area.
Riccardo Canevari, CEO and Managing Director, said, "These compelling interim data significantly strengthen confidence in the success of our Phase II trial of RAD 101 and provide a strong foundation for initiating a pivotal study by the end of 2026. Integrating RAD 101 PET with standard MRI has the potential to transform patient management and enable better treatment decisions for the more than 300 000 patients in the U.S. diagnosed with brain metastases each year."
Investors reacted strongly to the announcement, citing the high concordance rate, the Fast‑Track designation from the U.S. FDA, and the sizable market opportunity as key drivers of enthusiasm. The company’s market capitalization has grown as a result of the positive clinical data.
In addition to the RAD 101 milestone, Radiopharm announced that it has secured Australian approval to initiate a first‑in‑human Phase 1 trial of RAD 402 for metastatic prostate cancer, further expanding its pipeline and demonstrating the versatility of its radiopharmaceutical platform.
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