Latest Regulatory Approval News

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

Neurizon Therapeutics has locked in a $44 million funding package to fully support its lead drug NUZ-001 in the HEALEY ALS Platform Trial, marking a critical step toward potential regulatory approval and broader neurodegenerative applications.

Invion Limited’s partner Hanlim Pharm, backed by South Korea’s government grant, has secured up to A$2 million in non-dilutive funding to advance preclinical studies of HL270 for oesophageal cancer, paving the way for human trials in Australia.

Fenix Resources’ latest Scoping Study outlines a robust plan to ramp up Weld Range iron ore production to 10 million tonnes per annum by 2031, extending mine life to 2042 with significantly reduced costs and strong financial returns.

Hartshead Resources NL has entered a binding agreement for acquisition by ACAM GP Limited, offering shareholders a 133% premium and a clear exit from development risks. The scheme is set for implementation in early 2026, pending approvals.

Tempest Minerals has agreed to sell its Yalgoo Project to Capricorn Metals for $4.5 million in cash and shares, with additional payments tied to future discoveries and production milestones. The deal, expected to complete in early 2026, leaves Tempest retaining iron rights on key tenements while refocusing on other Western Australian assets.

VRX Silica Limited has announced a strategic leadership transition with Tony Swiericzuk appointed as CEO, succeeding Bruce Maluish who will step down in 2026 but remain on the board. This move positions VRX to advance its Arrowsmith North silica sand project towards production.

Audalia Resources has completed a $540,000 placement by issuing 20 million shares, aiming to advance mining design and permits at its Medcalf Project while exploring further funding options.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

Global Uranium and Enrichment Limited (GUE) has registered its scheme booklet with ASIC, detailing the proposed acquisition by Snow Lake Resources Ltd. The independent expert report supports the fairness and reasonableness of the deal, with GUE directors unanimously recommending shareholder approval.

Blue Star Helium has successfully started helium production at its Galactica project in Colorado, positioning itself as America’s newest helium producer with sales targeted for early 2026. The company’s strategic joint venture and low-cost operations underpin a promising growth trajectory amid rising helium and CO₂ demand.

Seven West Media shareholders have overwhelmingly approved the proposed acquisition by Southern Cross Media Group, clearing a major hurdle ahead of final court approval.