Latest Regulatory Approvals News

EMVision Medical Devices has secured US ethics approval for its pivotal multi-centre trial of the EMVision emu™ brain scanner, paving the way for a March 2025 trial start aimed at FDA clearance.

Suncorp Group Limited has announced a cash return of capital of AUD 3.00 per share, backed by shareholder and regulatory approvals, with payments scheduled for early March 2025.

Suncorp Group Limited has announced a combined ordinary and special dividend totaling AUD 0.63 per security, fully franked and backed by APRA approval for a capital reduction. The payment is scheduled for mid-March 2025.

Genesis Energy and New Zealand’s top generators are exploring extending Huntly Power Station’s life to address supply risks highlighted by winter 2024’s energy crunch.

Argenica Therapeutics reported a 16% reduction in half-year losses to $1.19 million, buoyed by a 29% increase in other income largely from R&D tax incentives, as it advances its neuroprotective drug development.

Structural Monitoring Systems’ subsidiary AEM has won full US Forest Service approval for its MTP136D radio, enabling deployment across all federally regulated US aerial firefighting aircraft and setting the stage for significant growth in 2025.

Memphasys has completed the final patient visit in its Felix™ clinical trial, with data lock expected within two weeks and preliminary results slated for early March 2025. This milestone paves the way for CE Mark submission and imminent commercialisation in Europe.

Koonenberry Gold has initiated a targeted diamond drilling campaign at its Enmore Gold Project in NSW, aiming to expand on historically significant gold mineralisation at the Sunnyside Prospect. This marks the first follow-up drilling since acquisition, with promising intercepts suggesting substantial upside.

Golden Horse Minerals updates its Southern Cross Project exploration with compelling soil geochemistry results revealing extensive gold anomalies and confirms acquisition of the Irene Betty lease, setting the stage for targeted drilling in 2025.

GTI Energy Ltd reports promising uranium leach test results from its Lo Herma project in Wyoming, demonstrating approximately 75% recovery rates consistent with regional ISR operations. These findings underpin the upcoming Scoping Study expected in H1 2025.

E79 Gold Mines has identified promising new drill targets at its Laverton South Project following significant gold mineralisation results from neighbouring Kalgoorlie Gold Mining Ltd. The company plans to initiate aircore drilling in the March Quarter to test these high-potential zones.

CSL Limited reported a solid half-year performance with 5% revenue growth and a 7% rise in net profit, driven by strong demand in its Behring and Vifor segments despite challenges in Seqirus. The company reaffirmed its full-year NPATA guidance of 10-13%, signaling confidence in its operational momentum.