Latest Regulatory Filings News

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.

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.

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.

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.

European Lithium has lodged the Scheme Booklet with ASIC for its proposed merger with Critical Metals Corp, advancing the regulatory process with a court hearing scheduled for mid-September.

Bio-Gene Technology narrowed its loss to $2.33 million in FY26 while progressing key toxicity studies for Flavocide and securing a commercial foothold for Qcide in Japan. The company bolstered its balance sheet with a $3.275 million capital raise to fund ongoing development and production scale-up.

Clinuvel Pharmaceuticals marked its tenth consecutive profit with stable revenues and rising cash reserves, while accelerating U.S. expansion including a Nasdaq uplisting and potential ASX delisting.

A2MP Investments has pushed back the deadline for its takeover bid for Canyon Resources, giving shareholders more time to review key documents amid ongoing conditionality.

Telix Pharmaceuticals returned to profit in H1 2026, driven by strong U.S. sales of Illuccix and Gozellix, a $40 million upfront from Regeneron collaboration, and expanded R&D investment.

Forrestania Resources and Zenith Minerals have formalised an amended takeover implementation deed, setting out detailed terms for Forrestania's bid including offer ratios, board changes, and break fees.

Jindalee Lithium has taken another regulatory step by filing an amended Form S-4 with the US SEC, progressing its plan to spin out US lithium assets via US Elemental and list on NASDAQ.