Latest Regulatory Reviews News

Yancoal's June quarter saw a 20% jump in attributable saleable coal production to 10.8 million tonnes, supported by rising realised coal prices and operational improvements. The company advances its strategic growth with the pending acquisition of an 80% stake in the Kestrel Coal Mine, while planning to close Ashton mine by early 2028.

Amaero has taken a key step toward listing in the US by confidentially submitting its draft registration statement to the SEC, though pricing and timing remain undecided.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Peter Warren Automotive’s planned acquisition of Wakeling Automotive hits a regulatory and timing impasse as vendors refuse to extend the deal’s Sunset Date despite ACCC application adjustments.

Po Valley Energy has lodged a crucial Environmental Impact Assessment for a four-well gas drilling program at its Selva Malvezzi concession in Northern Italy, aiming to boost production and support regional energy needs.

Melbana Energy halts direct involvement in its Cuban Block 9 project following US sanctions on CUPET, its contractual counterparty, while it seeks legal clarity on the complex regulatory landscape.

MRG Metals has lodged a key Mining Right Conversion Application in South Africa for its Garies Rare Earth Project, setting the stage for scalable mining development supported by strong metallurgical results and a modular processing approach.

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

Chorus has reported a rise in its fibre regulated asset base to NZD 6 billion for 2025, alongside a significant NZD 101 million under-earn on its maximum allowable revenue, resulting in a NZD 76.3 million wash-up balance to be carried into the next regulatory period.

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.