Latest Regulation News

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

Buru Energy has formally referred its 100%-owned Rafael Conventional Gas Project to Western Australia’s environmental regulator, with a decision on whether the project requires assessment expected by late 2026. The referral keeps the company’s targets of a final investment decision in the second half of 2027 and first gas in early 2029 in view, subject to approvals.

OFX Group is investigating unauthorised access to data involving some clients and people who have interacted with the company. The fintech says there is currently no evidence that client accounts, funds or services were affected, but the scope of the incident remains unclear.

Stakk has executed a five-year US$9 million agreement with US banking technology provider Candescent, with its AI-powered cheque and document intelligence already deployed. The contract commits approximately US$1.8 million in annual revenue through 2030 and is expected to contribute above Stakk’s FY2027 revenue milestone.

Metrics Real Estate Multi-Strategy Fund units will remain suspended on ASX after the fund failed to lodge its audited financial statements. Reinstatement now depends on the accounts being filed and ASX deciding that trading can resume appropriately.

Klevo Group has reported a sharp FY2026 turnaround, with revenue up 324%, positive operating cash flow and cash rising to A$4.32 million. The more striking claim is its KLVR stablecoin platform, which has recorded USD 59.2 million in unaudited revenue since trial commencement ahead of a planned commercial rollout.

Quixxi has secured a four-year A$635,238 contract with a major Italian industrial group for its Clarity AI governance platform. The win strengthens the case for WhiteHawk’s proposed acquisition, but WhiteHawk will not benefit financially unless shareholders approve the deal and completion follows.

Riversgold has lodged the Mine Development and Closure Proposal for its Northern Zone open-pit project near Kalgoorlie, moving the planned mine into its final major approval phase. The project remains conditional on regulatory sign-offs, but MEGA Resources is set to fund development under an extended cooperation agreement.

Booster has secured a further $7.4 million capital commitment for the Booster Innovation Fund, taking total committed and allocated capital above $23 million. The funding announcement arrives alongside disclosure of civil proceedings by New Zealand’s Financial Markets Authority and a new independent director.

Heartland shareholders have overwhelmingly approved the proposed acquisition of TSB and the creation of TSB Heartland Bank, advancing the transaction toward regulatory completion. The deal still faces outstanding conditions, including a Material Adverse Change test and required approvals.

Peak Processing delivered its first positive Group EBITDA quarter in FY2026, but the turnaround remains financially fragile. The ASX-listed THC beverage manufacturer reported a $7.8 million statutory loss, negative operating cash flow and an explicit material uncertainty over its ability to continue as a going concern.

Yancoal Australia has secured NSW approval to continue mining at Hunter Valley Operations until the end of 2045, clearing a major regulatory hurdle after a six-year process. Federal environmental approval remains outstanding, with a deadline of 31 December 2026.