Latest Radiopharm Theranostics (ASX:RAD) News

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

Radiopharm Theranostics reported a A$56.3 million comprehensive loss for fiscal 2026, with operating cash outflows rising to A$52.8 million and cash falling to A$4.1 million. The company says further funding is required, while auditors flag a material uncertainty over its ability to continue as a going concern.

Healthcare shares split sharply this week, with Biome Australia rising while Nanosonics, Epiminder and Saluda Medical fell heavily.
Profits, trial progress and new approvals competed with cash needs, debt concerns and weaker investor confidence.

Radiopharm Theranostics has dosed the first patient in the second cohort of its Phase 1/2a trial for RV-01, a radiopharmaceutical targeting B7-H3 expressing solid tumors, marking a key dose escalation milestone.

Healthcare shares delivered a mixed week, with strong gains at AVITA Medical, Australian Clinical Labs and CSL despite very different company results.
Investors also weighed new US approvals, clinical trial progress, funding needs and rising sales across the sector.

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.

Lumos led healthcare stocks higher after widening its US urgent care rollout, while Tissue Repair tumbled on its plan to leave the ASX. Strong trial updates, FDA steps and fresh funding kept the sector busy, even as several stocks fell despite good news.

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.

Healthcare stocks delivered a mix of capital raisings, product approvals and trial wins, but many early share price jumps did not last. The biggest moves came from Patrys, Firebrick Pharma and 4DMedical, where investors reacted fast to funding news and then kept testing how much near-term value was really on offer.

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.