RAD101

Oct. 05, 2026: Radiopharm Theranostics (ASX: RAD, NASDAQ: RADX) said it completed an FDA End-of-Phase 2 meeting for RAD101, an investigational 18F-labeled imaging agent targeting fatty acid synthase for detecting suspected recurrent brain metastases from solid tumors. The company said the FDA interaction provided a framework for the pivotal development plan, and it is starting Phase 3 readiness activities while awaiting official FDA meeting minutes expected within about 30 days.

Previously reported Phase 2b data showed RAD101 achieved 93% concordance with MRI across all evaluable lesions, meeting the trial’s primary endpoint. The company said RAD101 has FDA Fast Track designation to help distinguish recurrent disease from treatment effect in brain metastases, including leptomeningeal disease.

Radiopharm also noted a recent partnership with Siemens Healthineers to manufacture and distribute 18F-RAD101 doses for the planned U.S. Phase 3 registrational trial. In addition, it cited earlier Phase 2a imaging data from Imperial College London showing significant tumor uptake in brain metastases independent of tumor origin, with PET-MRI potentially serving as a non-invasive predictor of overall survival. The release also mentions potential future strategic partnering and a potential NDA submission, but no dates were provided.