Latest Radiopharm Theranostics (ASX:RAD) News

Radiopharm Theranostics reports significant progress in its oncology radiopharmaceutical pipeline, including FDA Fast Track designation and dose escalation approvals, supported by a solid cash runway through mid-2026.

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.

Radiopharm Theranostics has inked a clinical supply agreement with Cyclotek to support its Phase 1 trial of RAD 402, a novel radiotherapeutic targeting prostate cancer, set to commence in Australia in late 2025.

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.

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.

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.

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.

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.

Radiopharm Theranostics has secured key ethics approvals to expand its clinical trial portfolio, completed significant preclinical milestones, and raised A$8 million through a strategic placement, while maintaining its cash runway to mid-2026.