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Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3 On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25 SYDNEY, July 28, 2025 (GLOBE NEWSWIRE) -- 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, today announced that the U.S. Fo

articleRadiopharm Theranostics LimitedJuly 28, 20254/company/radiopharm-theranostics-ltd/news/radiopharm-theranostics-receives-ind-approval-from-us-fda-to-initiate-phase-i-therapeutic-clinical-study-to-target-b7h3-with-betabart-rv-01
Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)

About this update from Radiopharm Theranostics Limited

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MD Anderson Cancer Centermonoclonal antibodybiopharmaceutical companyPhase 1 clinical trialTheranosticsunmet medical needRiccardo CanevariradiopharmaceuticalsFood and Drug AdministrationRADXtargetimmune complexes