Latest Brain Metastases News

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Radiopharm Theranostics (ASX: RAD) has requested an immediate voluntary suspension of its shares pending a material capital raising announcement expected before markets open on 27 July 2026.

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

Radiopharm Theranostics (ASX: RAD) has completed enrolment in its Phase 2b RAD 101 brain metastases imaging trial with interim data showing 90% concordance with MRI, while progressing early-stage trials of therapeutic candidates RAD 202, RV-01, and RAD 402. The company reported a $19.2 million cash balance at quarter end, down from $34.5 million, with a net operating cash outflow of $14.9 million driven by milestone-related R&D and staff costs.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.

Radiopharm Theranostics reports promising second interim Phase 2b results for RAD 101, showing 90% concordance with MRI in detecting brain metastases and encouraging sensitivity and specificity trends.

Radiopharm Theranostics reported a 44% increase in net loss to $27 million for the half-year ended December 2025, driven by expanded R&D spending. The company bolstered its cash reserves through a $35 million placement while progressing multiple clinical trials across its radiopharmaceutical pipeline.

Radiopharm Theranostics has reported promising interim results from its Phase 2b trial of RAD 101, showing high concordance with MRI in brain metastases patients, while progressing multiple other clinical programs and securing a strong cash position to fund operations into 2027.