Latest Regulatory Update News

PT Aneka Tambang Tbk (ANTAM) reported a historic financial year in 2025, with revenue up 22% and net profit more than doubling to Rp7.92 trillion, driven by strong domestic demand and operational efficiency. The company also navigates evolving Indonesian mining regulations and ongoing legal challenges as it invests in downstream nickel projects.

Acrux Limited has secured a $0.55 million advance on its FY26 R&D Tax Incentive, providing crucial funding to accelerate development of its Hormone Replacement Therapy following FDA regulatory confirmation.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.

NeuroScientific Biopharmaceuticals reported a $1.7 million loss for the half-year ending December 2025, driven by ongoing R&D investments. The company progressed clinical treatments for Crohn’s disease and glaucoma, alongside key leadership appointments and strategic partnerships.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

Solvar Limited reported a 5.8% rise in half-year NPAT to $20 million, driven by the sale of its New Zealand written-off loan book and expanded debt facilities. The company also announced a special dividend and outlined growth plans in commercial lending.

Cann Group Limited has reported its first-ever free cash flow positive quarter, following a significant debt restructuring and a $9 million capital raise. Despite a softer quarterly revenue, the company is advancing new product launches and export partnerships, positioning itself for growth.

Electro Optic Systems (EOS) reports a record $459 million contract backlog, major new defence contracts including a $120 million laser weapon deal, and a strategic acquisition to boost counter-drone capabilities.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

MRG Metals has completed its acquisition of the Garies Rare Earth Project, adding a high-grade, magnet-rich rare earth asset in South Africa to its portfolio. This move significantly boosts the company’s exposure to critical minerals essential for emerging technologies.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Aumake Limited has obtained a Hong Kong pharmaceutical wholesale licence, enabling it to launch up to five online over-the-counter medicine stores targeting Chinese consumers. This strategic move positions the company to tap into China’s rapidly expanding OTC market.