Latest Regulatory Updates News

ANZ Group Holdings Limited posted a 14% rise in cash profit for 1H26 to AUD 3.78 billion, driven by cost reductions and steady revenue, while declaring an 83-cent interim dividend with 75% franking.

Premier1 Lithium completed its maiden RC drilling at Yalgoo and confirmed expanded gold anomalies at Rochefort through advanced geophysical surveys, setting up follow-up drilling in 2026.

Mayne Pharma’s third quarter results show modest revenue growth but a sharp improvement in cash flow and earnings, powered by the strong launch of DistributeRx and robust Women’s Health sales.

The Koala Company Limited has issued corrected Appendix 3X notices for directors Daniel Milham and Michael Gordon, clarifying escrow status and relevant interests in securities. This update follows a prior announcement on substantial holder notices and aims to ensure regulatory compliance.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

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.