Latest Radiopharmaceuticals 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.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

Telix will acquire ITM in a proposed US$1.65 billion deal that combines a commercial radioisotope supplier with Telix’s precision medicine and therapeutic pipeline. The transaction could give Telix greater supply-chain control and entry into a validated cancer treatment market, but it also brings dilution, integration risk and an unresolved FDA pathway for ITM-11.

Synertec has identified ANSTO as the client behind its $45.5 million engineering contract, with about $36 million of revenue expected during the first 26 months. The project could improve FY27 revenue, but the company has not yet revised its guidance.

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

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.

Cyclopharm Limited posted a fifth consecutive record half-year revenue of $17.5 million, propelled by a 74% jump in US Technegas® sales and a doubling of revenue-generating US sites. New US clinical guidelines naming Technegas® as the preferred ventilation imaging agent underpin a robust growth outlook despite a wider net loss.

IDT Australia reports a sharp turnaround in FY26 with a 66% reduction in net loss and an 85% improvement in EBITDA, underpinned by a strategic reset and targeted investments in manufacturing capabilities.

Telix Pharmaceuticals returned to profit in H1 2026, driven by strong U.S. sales of Illuccix and Gozellix, a $40 million upfront from Regeneron collaboration, and expanded R&D investment.