pp-235 Solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
Australia
GMP approvals
TGA
Comments
Indication: Prostate Cancer (biochemical recurrence) / Clinical stage: Phase 3 (AMPLIFY trial completed enrollment March 2026) / Modality: Biologic - copper-64 labeled PSMA-targeting radiopharmaceutical / Mechanism & Target: PSMA-directed imaging/therapy / Route & form: IV injection / Differentiation: Dual-targeting (bispecific) PSMA radiopharmaceutical
Manufacturer #39440
Australia-based clinical-stage radiopharmaceutical company developing next-generation Rx theranostic products for oncology using a proprietary platform. The approach pairs a diagnostic imaging isotope with a matched therapeutic isotope for targeted radiotherapy. Multiple clinical programs are advancing globally.
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