Latest Regulatory Filings News

Micro-X has told ASX it is unaware of any undisclosed information explaining the sharp move in its shares, which rose from $0.030 to $0.045 during 23 September trading. The company pointed to elevated volumes, earlier institutional selling and chairman Patrick O’Brien’s purchase of 1.36 million shares.

ReNerve has converted regulatory approvals into its first commercial NervAlign Nerve Cuff surgeries in Hong Kong and Malaysia, expanding activity to seven jurisdictions. The milestones arrive as FY26 sales climbed 88% to $510,357 and the company builds out its US distribution network.

Wrkr has outlined warnings, training and share-repurchase measures after 603,540 shares linked to non-executive director Emma Dobson were sold during a closed trading period. The company says the sale was inadvertent and occurred without Dobson’s knowledge, while committing to tighter controls around related-party trading.

Alcoa has filed South32’s meeting materials ahead of a shareholder vote on the proposed sale of bauxite, alumina and aluminium interests. The transaction remains subject to shareholder approval, regulatory clearance, financing and other closing conditions.

Optiscan Imaging has reached an 84-case milestone in its live digital pathology study with Australian Clinical Labs, testing the InForm platform across a broad range of tissue types and disease settings. The data may support future regulatory submissions and commercial discussions, but the announcement does not disclose diagnostic accuracy metrics or regulatory approval.

Regal Partners Global Investments has confirmed a DRP price of A$2.60635 for its 5.0-cent fully franked dividend. The update settles the reinvestment mechanics ahead of the A$0.05 cash payment due on 25 September.

OncoSil Medical has secured $5.6 million from its three largest institutional investors to fund commercial launches of its OncoSil device in the United States and Australia. The commitments follow FDA and TGA approvals and would lift pro-forma cash to $12.1 million once completed.

Income Asset Management Group has attributed a late director interest notice to an administrative oversight and miscommunication, after ASX questioned whether disclosure rules may have been breached. IAM says it has reiterated its director reporting process and will strengthen controls if required.

Cleo Diagnostics has received its first commercial batch of ovarian cancer test kits from Bio-Techne, marking the start of analytical validation critical for its FDA submission planned in early 2027.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.