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Previous comprehensive preclinical proof-of-concept Biodistribution studies of RAD 402 in mouse xenografts showed strong tumour targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody. Radiopharm has signed in 2022 a supply agreement with Terthera for the production of Tb161 and in 2025 with Cyclotek for radiolabeling RAD402 with 161Tb, supporting the initiation of the Phase 1 FiH trial of RAD 402.
"Receiving HREC approval marks a key milestone for Radiopharm and for patients in need of safer, more effective new treatments for prostate cancer," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "This clearance enables us to advance RAD 402 into our first-in-human Phase 1 clinical trial, which, to my knowledge, is the first company-sponsored therapeutic trial using 161Tb. We are highly encouraged by RAD 402's potential antitumor activity, driven by the dual emission of beta particles and Auger electrons from Tb-161. Targeting KLK3 in advanced prostate cancer represents a novel and promising mechanism of action. The strength of our preclinical data, combined with regulatory endorsement, underscores RAD 402's first-in-class potential"
Posted In: RADX
