Latest Regulatory Updates 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.

Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.

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.

Bubs Australia reports a 14% increase in half-year revenue, powered by a 47% jump in US sales, while other regions face challenges. The company remains optimistic about FDA approval and market recovery in H2 FY26.

Cokal Limited has advanced its metallurgical coal operations in Central Kalimantan with new mining contracts, resumed coal shipments, and infrastructure upgrades, aiming for a 2026 production target of approximately 420,000 tonnes.

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.

Infinity Metals has completed drilling at its Cobungra Gold-Copper-Silver Project in Victoria, confirming mineralisation over a 2km strike, while awaiting regulatory feedback on its San Jose Lithium Mining Licence Application in Spain.

Bioxyne Limited has posted a record $17.2 million in quarterly revenue for Q2 FY26, driven by strong growth in its cannabis and psychedelics segments alongside strategic international expansions.

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.