Latest Regulatory Filings News

Neuren has lifted its 2026 trofinetide income guidance to US$91 million-US$93 million after Acadia reported a 39% rise in Q3 DAYBUE sales and a US$35 million German launch milestone. Japan trial results also support a planned 2027 regulatory filing, although a launch remains subject to approval and a distribution partner.

Savannah Goldfields has paused Georgetown production after processing its available Big Reef ore, with mining not expected to resume until the second quarter of 2027. The company ended September with A$1.23 million in cash and remains reliant on a material financing transaction while its securities stay suspended.

Nexsen has secured ISO 13485 certification covering the design, development and manufacture of its StrepSure Group B Streptococcus diagnostic. The milestone strengthens the product’s regulatory and manufacturing platform, but does not yet amount to FDA or TGA approval.

Terramin Australia faces an ASX compliance test after lodging a director interest notice seven days after the exchange says it was due. The company must explain the delay and its disclosure controls by 4 November or risk a trading halt or suspension.

Manuka Resources has restarted gold production at Wonawinta and reached full processing capacity after quarter end, marking the first operating revenues from the plant. The stronger production narrative is tempered by A$581,000 in cash, A$60.1 million of borrowings and a reported funding runway of just 0.37 quarters on the September cash burn.

Accent Resources has reinforced its Magnetite Range strategy after independent testwork produced up to 68% Fe concentrate using a dry processing route. The company also reported cash of A$5.505 million, a Norseman sale worth up to A$4.0 million and an 11,568-metre drilling campaign now underway.

Pathkey.AI has secured its first Chipforge customer contract ahead of the semiconductor platform’s commercial release, while a $2.8 million placement lifted quarter-end cash to $5.83 million. The company remains early-stage, with just $10,000 in customer receipts during the September quarter and further commercial conversion still to prove.

European Metals says a single tunnel kiln could cut Cinovec’s capital cost by about US$112 million and operating costs by US$10 million a year, but the savings remain preliminary. The company also has until 13 November to secure EUR6.448 million if it wants to restore its 49% stake in the project vehicle.

Far East Gold’s cash position has tightened sharply, with only A$593,000 remaining after a September quarter of takeover costs and exploration spending. The company says it needs new funding while a board-control fight threatens to add further uncertainty.

Activeport’s Q1 FY27 revenue rose 18% to A$1.72 million as software sales more than doubled, while a completed restructure promises A$2 million in annualised savings. The sharper growth story arrives with a pressing funding question: quarter-end cash covered only 0.7 quarters of reported operating outflows.

Macro Metals lifted mining services work performed to approximately A$2.8 million in the September quarter as its first BHP Mt Goldsworthy package ran ahead of schedule. The operational progress comes alongside a thin A$392,000 quarter-end cash balance, followed by a proposed A$3.28 million funding package to accelerate Pilbara exploration.

KTEK Aerosystems has restarted deliveries under its main production program and is targeting 150 complete airframe sets per month. But the recovery is entering its most demanding phase, with A$2.31 million of quarterly operating cash outflow and only 1.1 quarters of funding under the ASX measure.