Latest Theranostics News

Radiopharm Theranostics has received an $8 million advance against its anticipated FY26 Australian R&D tax incentive, giving the clinical-stage company additional funding for trials and working capital. The facility carries commercial interest and must be repaid by 26 October 2027.

Starpharma has submitted its European trial application for DEP HER2-Lu and completed manufacture of clinical material, bringing its lead radiopharmaceutical closer to first patient dosing. The biotech also took control of Petalion, collected a Radiopharm option fee and finished the quarter with AUD $34.4 million in cash.

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.

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.

Neurizon has appointed Dr Chris Bremer as chief executive as its NUZ-001 ALS program moves towards topline Phase 2/3 results expected in late Q2 2027. The incoming CEO brings more than 20 years of pharmaceutical and biotechnology experience, including over US$1 billion in licensing transactions.

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

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.

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.

Clarity Pharmaceuticals bolsters its commercial readiness with a $178.3 million cash reserve and a key US manufacturing agreement, while clinical trials for its prostate cancer imaging and therapeutic agents progress with promising data.

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.