Latest Regulatory Review News

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.

PEXA faces a proposed 20% cut in regulated ELNO service fees, risking a $70 million revenue reduction over a year. The company urges a phased approach to mitigate business impact as IPART opens public consultation.

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.

Quinbrook Asset Management has lodged a review application challenging a recent Takeovers Panel decision involving Kingsland Minerals. The Panel President has approved the application, but no review Panel has been formed yet.

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.

Peter Warren Automotive has withdrawn its initial ACCC application for the Wakeling Automotive acquisition, opting to submit a fresh Phase 1 proposal with remedies to secure regulatory approval.

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.

The ACCC has moved Peter Warren Automotive’s acquisition of Wakeling Automotive’s 30 dealership sites into a Phase 2 review amid concerns it could dominate Sydney’s Macarthur region new car market, controlling 25 of 33 dealerships locally.

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.