Latest Regulatory Milestones News

Tungsten Mining NL’s Pre-Feasibility Study confirms Mt Mulgine as a world-scale tungsten project, targeting first production in mid-2029 with robust economics and low operating costs.

Neurizon has appointed Dr Chris Bremer as chief executive as its NUZ-001 ALS program moves towards topline Phase 2/3 results expected in late Q2 2027. The incoming CEO brings more than 20 years of pharmaceutical and biotechnology experience, including over US$1 billion in licensing transactions.

Maronan Metals appoints experienced mining executive Andrew Graham as Managing Director and CEO, marking a key leadership transition to advance its Maronan Project through drilling and feasibility milestones.

Maronan Metals has marked a transformative year with a positive Preliminary Economic Assessment, grant of a key Mineral Development Licence, and two capital raises totaling nearly A$40 million, positioning the company for accelerated development of its Queensland silver-lead and copper-gold project.

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Osteopore Limited’s half-year results show an 8% revenue drop driven by currency effects, while losses widen 14% as the company invests heavily in product development and market growth.

Peppermint Innovation Limited posted a $2.4 million net loss for FY26 as it shifted from platform development to commercial execution in the Philippines, achieving key regulatory milestones and securing strategic investment.

Invex Therapeutics posted a $1.35 million net loss for FY2026, driven by expanded R&D efforts and a deepening collaboration with Tessara Therapeutics targeting neurological diseases including Alzheimer’s. The company renewed its orphan drug status in Europe and restructured its board during the year.

Recce Pharmaceuticals narrowed its operating loss to AUD 15 million in FY26, progressing Phase 3 trials for its anti-infective RECCE 327 and securing key patents and commercial partnerships.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.