Latest Regulatory Milestones News

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.

Jade Gas Holdings has lodged its initial Plan for Development of Operations and secured approval for a substantial 502 km² production licence area, marking pivotal steps towards commercialising Mongolia’s first coal bed methane project.

Dimerix has received a US$10 million upfront payment from Everest Medicines under a regional licensing deal for DMX-200 targeting FSGS in Greater China, South Korea and Southeast Asia. This deal marks Dimerix’s fifth commercial partnership for DMX-200, collectively worth up to A$1.9 billion in milestones and royalties.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

BHP Group Limited posted robust FY2026 results with a 15% revenue increase, record copper production contributing over half of underlying EBITDA, and a total fully franked dividend of 172 US cents per share. The company advances growth projects, including the Jansen potash mine, while managing legacy Samarco liabilities and pursuing climate targets.

Bathurst Resources is set to submit a Fast Track Approvals Act application for its Buller Plateaux Continuation Project, aiming to unlock 20 million tonnes of coking coal over 25 years on New Zealand’s West Coast.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

Anteris Technologies posted a $51.7 million loss in H1 2026 amid ramped-up R&D and clinical trial activity, supported by a $320 million capital raise and Medicare reimbursement for its DurAVR heart valve trial.

EBR Systems marked a commercial milestone with over 100 WiSE CRT implants and secured purchasing agreements with three major US healthcare networks. The company is progressing toward Medicare coverage and scaling manufacturing, supported by a near-complete A$150 million capital raise.

Lake Resources has completed a A$1.1 million at-the-market equity raise at a 7.6% discount, directing funds towards advancing environmental and power optimisation efforts at its Kachi lithium project.