First RECIST-confirmed durable Partial Response at current highest dose level #3 (90mCi) with the patient remaining progression free beyond seven months Second patient dosed remains progression free on treatment with RAD204 with early tumor shrinkage observed after first treatment RAD204 is

Radiopharm Theranostics (ASX:RAD) is an asset listed on the ASX, and part of the Health Care sector. Grafa’s asset page shows Radiopharm Theranostics’s share pr

Data Safety Monitoring Committee approves advancing to a higher dose of 90mCi The first two Cohorts’ patients show tumor uptake and a favourable safety profile SYDNEY, Nov. 12, 2025 (GLOBE NEWSWIRE) -...

On track to complete enrollment of first two cohorts of RAD204 following positive recommendation from DSMC to escalate dose to 60mCi of Lu177 On track to complete enrollment of the first cohort of Pha...

GARCHING / MUNICH, Germany and SYDNEY, May 19, 2025 (GLOBE NEWSWIRE) -- ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Radiopharm Theranostics (ASX:RAD; N...

Reported Wednesday, Nov 12 - 8:34am EST (TheFly subscription required to read more.)

Radiopharm Theranostics (NASDAQ: RADX) announced on Nov 12, 2025 that enrollment of the second cohort is complete in the open-label Phase 0/1 trial of 177Lu-RAD204 in PD-L1 positive advanced cancers.The Data Safety Monitoring Committee approved escalation to a higher dose of 90 mCi for the Third Cohort. The first two cohorts showed tumor uptake and a favourable safety profile. The basket trial includes NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC and endometrial cancer and will continue to collect safety, biodistribution, dosimetry and preliminary anti-tumour data.

Radiopharm Theranostics (NASDAQ: RADX), a clinical-stage biopharmaceutical company, reported significant progress across its radiopharmaceutical pipeline for FY2025. Key developments include FDA Fast Track Designation for RAD101 for brain metastases treatment differentiation, positive DSMC recommendation for RAD204 dose escalation to 60mCi, and advancement in the Phase 1 'HEAT' trial of RAD202 for HER2-positive tumors.The company maintains a strong financial position with cash balance of $29.12 million, up from $18.58 million year-over-year, providing runway through mid-2026. Notable achievements include IND clearance for RV-01, strategic supply agreements with ITM and Cyclotek for radioisotopes, and progression across multiple clinical trials with data readouts expected in H2 2025.

Radiopharm Theranostics (RADX) has received approval from the Data Safety and Monitoring Committee (DSMC) to proceed with dose escalation in its Phase 1 clinical trial of 177Lu-RAD204 for PD-L1 positive advanced cancers. The DSMC reviewed the first cohort of four patients treated with 30mCi and confirmed positive safety, pharmacokinetic, and biodistribution data.The second cohort will receive an increased dose of 60mCi (higher than the previously planned 40mCi). The trial is expanding beyond Non-Small Cell Lung Cancer to include multiple tumor types such as Small-Cell Lung Cancer, Triple-negative Breast Cancer, Cutaneous Melanoma, head and neck cancer, and Endometrial Cancer. The company expects to complete enrollment of the first two cohorts by mid-2025, with four clinical trial sites actively recruiting in Australia.