Recent Updates — RADX
Radiopharm Theranostics has received an $8,000,000 advance under a funding facility secured against its anticipated FY26 Research and Development Tax Incentive (RDTI) from the Australian Taxation Office. The capital was provided by Rockford Capital at a commercial interest rate, with repayment due by October 26, 2027, or earlier without penalty. The funds will support the company's clinical trial pipeline and general working capital. Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing innovative radiopharmaceutical products for diagnostic and therapeutic applications in cancer.
Radiopharm Theranostics issued 140,028,000 unquoted options to employees on October 19, 2026, under its Omnibus Incentive Plan. The issuance was exempt from shareholder approval under ASX Listing Rule 7.2(13). Key management personnel received a significant portion of the grant, with Dimitris Voliotis allocated 30,887,000 options. Concurrently, four directors cancelled a total of 4,888,888 listed options due to expiration or cancellation. The company develops and commercializes radiopharmaceuticals for diagnostic imaging and targeted radionuclide therapy.
Radiopharm Theranostics completed a constructive End-of-Phase 2 meeting with the U.S. Food and Drug Administration regarding RAD101, an investigational Fluorine-18-labeled imaging agent targeting fatty acid synthase for detecting recurrent brain metastases. The interaction provided a clear framework for the pivotal clinical development plan in brain metastases imaging. The company is advancing Phase 3 readiness activities and expects to receive official FDA meeting minutes within approximately 30 days. RAD101 previously demonstrated 93% concordance with MRI in Phase 2b trials and holds Fast Track Designation. Radiopharm Theranostics is a clinical-stage radiopharmaceutical company developing diagnostic and therapeutic products for cancer.
Radiopharm Theranostics announced that positive interim data from its Phase 2b imaging trial of RAD101 was selected for a late-breaking oral presentation at the Society of Neuro-Oncology Annual Meeting. The data demonstrated 93% concordance between RAD101 PET and MRI across all evaluable lesions, meeting the primary endpoint. Additionally, preliminary sensitivity was 86% based on six-month follow-up or biopsy data in 14 patients. The company plans to meet with the FDA on October 1, 2026, to align on a Phase 3 pivotal trial protocol and has partnered with Siemens Healthineers for manufacturing and distribution support. Radiopharm Theranostics operates in the biotechnology industry, developing radiopharmaceuticals for oncology diagnostics and therapeutics.