Latest Administration News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

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.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

Metrics Income Opportunities Trust has released its audited FY2026 accounts, correcting the classification of valuation reductions while reporting an $18.2 million loss and a lower NTA. KPMG issued an unqualified opinion, but ASX has yet to determine when MOT units will resume trading and underlying funds remain closed to applications and redemptions.

Centaurus Metals has signed the contract securing initial 20MW of 230kV grid power for its Jaguar nickel project in Brazil. The infrastructure milestone removes one development hurdle, while funding negotiations and final connection approvals remain outstanding.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

DPM Metals says its Vareš operation remains open after Bosnia and Herzegovina’s Constitutional Court found the concession agreement and related land acts were not constitutionally compliant. Authorities now have six months to review the arrangements, leaving the mine operating but its legal framework unresolved.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

Victor Group Holdings’ audited FY2025 accounts were materially worse than its preliminary figures, with loss before tax rising to AUD 9.33 million from AUD 275,449. Newly recognised impairments and a sharp increase in depreciation turned preliminary comprehensive income of AUD 48,679 into a AUD 9.06 million loss.

Nutritional Growth Solutions has completed its acquisition of Sprout Organic, installing founder Selasi Berdie as CEO and reshaping the group around infant, toddler and children’s nutrition. The deal lifts shares on issue to 964 million, while management targets A$870,000 in annualised savings.

Investor Centre’s FY2025 report lays bare the financial strain behind its proposed revival: revenue collapsed, cash fell to just $3,320 and liabilities exceeded assets by $3.81 million. The company is now relying on an unsecured Lake Volta Investments facility and a non-binding restructuring plan after its brokerage subsidiary lost its AFSL.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.