Radiopharm Selected For Late-Breaking Presentation Of Positive RAD101 Phase 2b Data; Stock Up
(RTTNews) - Radiopharm Theranostics (RADX) announced that positive interim data from its U.S. Phase 2b imaging trial of 18F-RAD101 in patients with suspected recurrent brain metastases has been selected for a late-breaking oral presentation at the 31st Annual Meeting of the Society of Neuro-Oncology (SNO26), scheduled for November 12-15, 2026, in Philadelphia.
RAD101 is an investigational PET imaging small molecule targeting fatty acid synthase (FASN), which is overexpressed in cerebral metastases from solid tumors.
The product is being developed to help distinguish recurrent brain metastases from treatment-related changes following therapy.
Previously reported interim results showed 93% concordance between RAD101 PET and MRI across all evaluable lesions, meeting the trial's primary endpoint.
RAD101 also demonstrated substantial and selective tumor uptake, including metabolic activity in lesions where MRI findings were equivocal.
Among 14 patients with evaluable six-month follow-up and/or biopsy data, RAD101 showed preliminary 86% sensitivity, representing a positive trend toward its ability to identify recurrent disease.
Phase 2b Trial
The U.S. multicenter, open-label, single-arm Phase 2b trial is evaluating RAD101 in 30 evaluable patients with suspected recurrent brain metastases from solid tumors following stereotactic radiosurgery.
The primary endpoint is concordance between RAD101 PET-positive lesions and equivocal lesions identified through gadolinium-enhanced MRI.
Secondary endpoints include the sensitivity and specificity of RAD101 in distinguishing tumor recurrence from radiation-associated changes in previously treated brain metastases.
Radiopharm plans to use the Phase 2b findings to support a pivotal, global Phase 3 imaging trial.
The company expects to meet with the FDA on October 1, 2026, to align on the Phase 3 protocol.
RAD101 Development
RAD101 has received FDA Fast Track designation for distinguishing recurrent disease from treatment effects in brain metastases originating from different solid tumors, including leptomeningeal disease.
Radiopharm recently partnered with Siemens Healthineers to manufacture and distribute doses of 18F-labeled RAD101 in support of the upcoming U.S. Phase 3 trial.
The company estimates the U.S. brain metastases imaging market has more than 300,000 patients diagnosed annually and a total addressable market of approximately $600 million.
There are currently no approved PET products specifically for brain metastases imaging.
RADX has traded between $1.97 and $16.25 over the past year. Currently, the stock is trading at $1.98,up 0.17%.
