Latest Regulatory News

Nyrada has moved its PROTECT-MI heart-attack trial into active recruitment, with four hospitals open and three patients dosed. The biotech also reported supportive US FDA feedback, encouraging preclinical oncology data and AU$13.72 million in cash after a AU$12 million placement.

Cleanaway has signed a binding scheme implementation deed for EQT Infrastructure to acquire the waste services group for approximately $9.3 billion. Shareholders are being offered $3.095 cash per share, subject to approvals and any dividends paid before completion.

Northern Minerals will not hold its delayed 2025 AGM or 2026 AGM on 25 November after ASIC granted more time amid suspected non-compliance with federal share disposal orders. Both meetings must now be held by 31 March 2027, unless Treasury confirms compliance earlier.

Oceana Metals has completed its acquisition of the Serra Negra rare earths and niobium project in Brazil, turning an exploration proposal into its central operating asset. Four diamond rigs are now drilling toward a maiden JORC resource, although two mining-right amendments and part of the transaction consideration remain unresolved.

ECS Botanics has delivered a fifth consecutive quarter of positive operating cash flow, while branded sales and international expansion continue to reshape the business. The next test is whether planned UK and Polish launches can convert into recurring revenue.

Algorae has secured exclusive Australian commercial rights across eight Umedica-branded molecules while separately advancing a Umedica-supplied product towards regulatory approval. The broader arrangement remains partly non-binding, with financial terms undisclosed and TGA approval still pending.

Cryosite delivered record first-quarter results, with revenue up 17% to $4.6 million and EBITDA rising 31% to $1.3 million. The more consequential test now sits with the TGA, which has audited the company’s Auburn facility as part of a potential licence expansion.

AdAlta expects an additional R&D Tax Incentive refund of more than A$1 million after securing approval for specified overseas work on its EW-001 CAR-T therapy. The cash benefit arrives as the company prepares for a US FDA pre-IND meeting in November.

Medallion Metals is moving towards first gold production, with Cosmic Boy processing scheduled to begin this month and initial sales expected in November. At Kundip, the first box-cut blast is complete and underground development remains targeted for December.

Jade Gas has begun drilling Mongolia’s first multilateral coal bed methane well at Red Lake, testing a five-branch design intended to improve future production. The milestone arrives as negotiations for a proposed US$762.5 million Phase 1 development advance, but binding agreements are now targeted for November.

South32 has maintained FY27 production guidance across every operation, while Sierra Gorda delivered stronger copper output and Hermosa cleared a major permitting hurdle. The quarter also exposed a sharp Cannington setback, with zinc-equivalent production falling 27% as paste backfill constraints disrupted mining.

FleetPartners has agreed to a $1.131 billion cash takeover by SG Fleet after a competitive auction lifted the offer to $5.30 per share. The deal still requires shareholder, court and regulatory approval, with completion targeted for March 2027.