RAD101

Aug. 17, 2026: Radiopharm Theranostics (ASX:RAD, NASDAQ:RADX) said the FDA has scheduled an End-of-Phase 2 meeting for October 1, 2026 for RAD101, an 18F-labeled FASN-targeted imaging agent, to align on the design of a pivotal Phase 3 trial in patients with suspected recurrence of brain metastases after radiotherapy.

The company said the Phase 2b trial met its primary endpoint, showing 93% concordance with MRI across all evaluable lesions. It also reported substantial and selective tumor uptake, with PET images confirming metabolic activity where MRI findings were equivocal. The FDA discussion will cover Phase 3 design elements including patient numbers and primary/secondary endpoints, and the company said it remains on track to be Phase 3-ready by year-end 2026.

RAD101 has FDA Fast Track designation for distinguishing recurrent disease from treatment effect in brain metastases from solid tumors, including leptomeningeal disease. Radiopharm also said Siemens Healthineers will manufacture and distribute 18F-RAD101 doses for the planned U.S. Phase 3 registrational trial.

The release also cites prior Phase 2a imaging data from Imperial College London showing significant tumor uptake independent of tumor origin.