Latest Regulatory Submissions News

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Paradigm Biopharmaceuticals has strengthened its balance sheet with a combined $5.75 million cash inflow from Australian Government R&D tax incentives, supporting its pivotal Phase 3 osteoarthritis trial and regulatory efforts.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

Recce Pharmaceuticals secured a non-binding term sheet with a major Middle Eastern pharma for its diabetic foot infection treatment and raised A$4 million to fund pivotal Phase 3 trials in Australia and Indonesia.

Orbminco has completed key drilling and metallurgical milestones at Majestic North, keeping its development timeline on track for a September Mining Development and Closure Proposal lodgement and final investment decision.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

Kinetiko Energy is progressing rapidly from exploration to production with a major onshore gas discovery in South Africa, targeting first commercial compressed natural gas by late 2027 through a phased, capital-efficient development.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Orthocell Ltd delivered a standout FY26 with 44% revenue growth to A$13.2 million, powered by accelerating US sales of its nerve repair product Remplir and a robust cash position supporting further expansion.