Latest Regulatory Filings News

Anteris Technologies has secured regulatory green lights for its pivotal PARADIGM trial and raised $25.2 million in capital, advancing its innovative DurAVR® transcatheter heart valve towards commercialisation.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Avecho Biotechnology has received patent allowances in the US and Europe for its proprietary CBD soft-gel formulation, reinforcing its intellectual property ahead of pivotal Phase III insomnia trial results expected in mid-2026.

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Ovanti Limited’s U.S. BNPL arm, Flote, has signed a Letter of Intent with Nasdaq-listed Miluna Acquisition Corp for a $300 million valuation, aiming for a Nasdaq listing while preserving Ovanti’s majority ownership.

C29 Metals has explained a delayed filing of a director interest notice as an isolated administrative oversight, reaffirming its compliance policies.

Activeport Group Ltd has revised the timetable for its pro-rata bonus issue of unquoted options, outlining key dates and eligible shareholders across multiple countries.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

Elementos Limited has issued 17.5 million shares at 28 cents each as part of a strategic placement, with further shares planned for January 2026, positioning itself to capitalize on growing tin demand.

Coronado Global Resources has finalized its financial support agreement with Stanwell Corporation, cementing previously disclosed terms and providing clarity on its capital position.

Recce Pharmaceuticals has secured a key patent in Hong Kong for its synthetic anti-infectives, reinforcing its intellectual property footprint in Asia and supporting its clinical and commercial ambitions in the region.