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Radiopharm Theranostics announced it has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug…

RDPTFRadiopharm Theranostics Ltd

Radiopharm Theranostics announced it has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration for October 1, 2026, to align on the design of a pivotal Phase 3 trial for RAD101 in patients with suspected recurrent brain metastases following radiotherapy. The company highlighted that its Phase 2b trial demonstrated 93% concordance between PET imaging using RAD101 and MRI across all evaluable lesions, meeting the primary endpoint. Radiopharm aims to be Phase 3-ready by year-end 2026, supported by a partnership with Siemens Healthineers for manufacturing and distribution in the U.S. The company operates in the clinical-stage biopharmaceutical industry, developing innovative oncology radiopharmaceuticals for diagnostic and therapeutic applications.

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