Latest Theranostics News

Radiopharm Theranostics has secured FDA Fast Track designation for RAD101, a novel imaging agent aimed at improving diagnosis of recurrent brain metastases. The move could speed development and regulatory review as the company advances its Phase 2 clinical trial.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

Radiopharm Theranostics has initiated dosing in its Phase 1 HEAT trial of 177Lu-RAD202, a novel radiotherapeutic aimed at advanced HER2-positive solid tumors, marking a key step in its clinical development.

Radiopharm Theranostics has unveiled encouraging preclinical results for its Lu177-B7H3 monoclonal antibody, RV01, paving the way for a mid-2025 Investigational New Drug submission and a Phase 1 trial later that year.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

ITM Isotope Technologies Munich SE and Radiopharm Theranostics have entered a strategic supply agreement for the critical radioisotope Lutetium-177, underpinning Radiopharm’s clinical development of targeted cancer therapies.

Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.

Clarity Pharmaceuticals reports a robust cash position and strategic refocus on its lead prostate cancer asset, Cu-SAR-bisPSMA, supported by multiple FDA Fast Track designations and advancing clinical trials.

Radiopharm Theranostics has bolstered its cash position with an $8 million placement from Lantheus Holdings, now its largest shareholder. New clinical data highlight promising advances in brain metastases detection and HER2-targeted radiopharmaceutical therapies.

Clarity Pharmaceuticals has expanded its breast cancer pipeline by introducing 64/67Cu-SAR-trastuzumab, supported by promising pre-clinical data and a new supply agreement for trastuzumab, aiming to address the unmet needs in HER2-positive breast cancer treatment.

Radiopharm Theranostics' RAD 101 radiotracer demonstrates high sensitivity in detecting brain metastases using a novel PET-mpMRI approach, with a Phase 2b trial now recruiting in the US.

Clarity Pharmaceuticals reports robust progress in its SECURE trial and secures FDA Fast Track Designation for its diagnostic agent 64Cu-SAR-bisPSMA, underpinning its growth and innovation in prostate cancer treatment.