Latest Regulatory News

Cleo Diagnostics has moved its pre-surgical ovarian cancer test into formal Analytical Validation, a key regulatory step before its planned FDA 510(k) submission in the first half of 2027. The three-batch program is expected to take about three months, but no validation results have yet been reported.

Arena REIT says Edge Early Learning has agreed or signed term sheets to sell a further 22 centre businesses, including all seven remaining Edge-operated centres at Arena properties. Rent continues to flow across the 27 affected properties, but operator changes still require due diligence, approvals and lease assignments.

Nyrada has received supportive written feedback from the US FDA on its proposed pathway for taking Xolatryp into a US Phase IIa heart-attack trial. The regulator identified no major issues, but additional information and stability data are still required before the planned IND submission in the first half of 2027.

Mesoblast has reported a sharp commercial step-up in FY2026, with Ryoncil generating US$115.2 million in net sales and total revenue reaching US$120.3 million. The company has also completed treatment in its 350-patient back-pain trial and refinanced its debt, but remains loss-making and expects to need more capital beyond the next 12 months.

Echo IQ has secured an FDA supervisory review of the regulator’s Not Substantially Equivalent decision for EchoSolv HF. The review creates a formal route for reconsideration, but does not change the current regulatory determination or guarantee clearance.

First Au has agreed to acquire the Ida Valley Gold Project in Western Australia for A$100,000 in cash and A$100,000 in shares. The project comes with historical drilling across two prospects, but the data still needs to be validated and the transaction remains conditional.

Acrux says the FDA has confirmed the evidence package required to take its female testosterone spray into Phase III trials for postmenopausal women with HSDD. The agency also indicated the company may apply for three years of data exclusivity if the product reaches submission.

Cooper Metals is pursuing an 85% interest in the Colet Copper Project in the Philippines, anchored by a large but unvalidated historical copper estimate. The acquisition would more than double the company’s share count and requires shareholder approval alongside a A$4.85 million capital raising.

Peet has lodged its draft scheme booklet, including the independent expert’s report, with ASIC as the proposed Ingenia takeover advances towards a shareholder vote. The transaction is targeted for implementation in late December, subject to regulatory, court and shareholder approvals.

EBR Systems reported 40 WiSE commercial implants in Q3, down from 46 in Q2 and below its prior forecast, as leadership changes and a sales strategy reset disrupted activity. Higher Medicare reimbursement and progress at its new manufacturing facility offer potential offsets, but both remain dependent on execution and regulatory approval.

AXP Energy has launched a 1-for-1 non-renounceable entitlement offer seeking between A$1.2 million and A$2.249 million. The funding could support Oklahoma development, but the prospectus also highlights material going-concern uncertainty, creditor dependence and significant dilution for shareholders who do not participate.

Altitude Minerals is abandoning its Byrock copper-gold earn-in after disappointing assays and redirecting exploration towards drill-ready silver and gold targets in Nevada. The pivot comes with $817,000 in cash, 1.5 quarters of estimated funding and further capital still to be secured.