Radiopharm schedules FDA end-of-Phase 2 meeting to align Phase 3 trial design for RAD101 brain metastases imaging agent

• Radiopharm Theranostics scheduled an Oct. 1, 2026 FDA end-of-Phase 2 meeting to align on a pivotal Phase 3 trial for RAD101.
• Phase 2b results were already presented, supporting the diagnostic performance of the PET imaging agent in suspected recurrent brain metastases.
• The Phase 3 plan targets patients with suspected recurrence following radiotherapy, aiming to clarify disease versus treatment-related changes.
• Management expects to be Phase 3-ready by year-end 2026, setting up a registrational pathway for the imaging product.
• Siemens Healthineers will manufacture and distribute U.S. doses for the upcoming Phase 3 program, supporting trial execution and supply readiness.

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