Radiopharm Theranostics Reaches FDA Alignment on Phase 3 Trial of RAD101 for Brain Metastases

• Radiopharm Theranostics reached agreement with the FDA on a single pivotal Phase 3 trial of RAD101 for assessing brain metastases.
• The study will enroll approximately 280 previously irradiated patients to evaluate RAD101’s ability to distinguish recurrent tumors from treatment-related changes.
• Previously reported Phase 2b results showed selective tumor uptake, including in lesions with inconclusive MRI findings.
• Site activations and patient dosing are expected to begin in the first half of 2027.
• Siemens Healthineers will manufacture and distribute radiolabeled RAD101 doses for the U.S. registrational trial.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Radiopharm Theranostics Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202611040700PRIMZONEFULLFEED1001301642) on November 04, 2026, and is solely responsible for the information contained therein.