On August 17, 2026 Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1st , 2026, to align on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with suspected recurrence of brain metastases following radiotherapy. RAD101 is 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 tumors.
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The focus of the meeting will be to align on the pivotal Phase 3 clinical trial design criteria, including the number of patients to be enrolled along with primary and secondary endpoints. The regulators will also be reviewing the data from the Phase 2b trial of RAD 101, which demonstrated 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101, with images confirming metabolic activity in PET compared to equivocal MRI findings.
"We are pleased to have secured an End-of-Phase 2 meeting with the FDA for RAD101, an important milestone that brings us closer to advancing this promising imaging agent into a pivotal Phase 3 program," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We believe the upcoming discussion will provide important alignment on the clinical and regulatory pathway forward, enabling us to finalize plans for a registrational study and remain on track to be Phase 3-ready by year-end. Supported by the strong Phase 2b data demonstrating 93% concordance with MRI, we believe RAD101 has the potential to address a meaningful unmet need in the diagnosis of recurrent brain metastases and create significant value for patients, clinicians, and shareholders."
RAD 101 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 disease. The company also 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.
In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1
About RAD101
RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.
(Press release, Radiopharm Theranostics, AUG 17, 2026, View Source [SID1234670195])