Latest Regulatory Submissions News

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.

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.