Latest Regulatory News

Mayne Pharma has clarified why it did not disclose an FDA Untitled Letter to the market despite sharing it with its scheme bidder, reaffirming compliance with ASX rules amid recent share price volatility.

OD6 Metals has secured regulatory approval to launch an 18-hole, 5,000-metre drilling program at its Gulf Creek Copper Project, targeting promising repeat mineral structures. A further 7-hole deep drilling phase awaits approval, potentially expanding exploration near historic high-grade copper zones.

Ventia Services Group Limited delivered strong financial results for 2024, highlighted by a 12.8% rise in NPATA and a record 92% contract renewal rate, while reaffirming growth guidance despite ongoing ACCC proceedings.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Rapid Lithium Limited has agreed to acquire two high-grade silver projects in New South Wales, adding nearly 35 million silver equivalent ounces to its portfolio. The deal, valued at A$6.5 million, signals a strategic diversification into critical minerals amid a robust silver market.

Hutchison Telecommunications (Amsterdam) B.V. has announced an off-market takeover bid for the 12.13% of Hutchison Telecommunications (Australia) Limited shares it does not already own, offering a 52.4% premium. The move aims to consolidate full ownership of the Australian telecom operator.

Zelira Therapeutics has published full results from a Phase I study showing its cannabinoid-based therapy ZLT-L-007 significantly outperforms Lyrica® in managing diabetic neuropathy pain and related symptoms.

Lincoln Minerals’ Kookaburra Graphite Project has delivered battery-grade graphite purity exceeding 99.95%, confirming its suitability for lithium-ion battery anodes through a safer, hydrofluoric acid-free process.

Argenica Therapeutics has expanded its intellectual property with a new US patent targeting surgically induced strokes, enhancing the commercial potential of its lead drug candidate ARG-007.

Arika Resources has identified 10 significant new gold targets at its Ithaca Prospect near Genesis Minerals’ Ulysses-Orient Well operation, setting the stage for upcoming drill testing at the Kookynie Gold Project.

New Frontier Minerals advances its NWQ Copper Project by securing bulk sample processing at Austral Resources’ Mt Kelly plant, accelerating its path to copper production in Queensland’s Mt Isa Copper Belt.

Smart Parking Limited reports robust H1 FY25 growth driven by a strategic US acquisition and expanding global footprint, underpinned by proprietary AI technology.