Latest Regulatory Milestones News

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Lumos Diagnostics has reached a key enrolment milestone in its BARDA-backed FebriDx paediatric trial, unlocking a US$670,000 payment and advancing its FDA submission pathway to expand use in children aged 2-12 years.

Finder Energy (ASX:FDR) is advancing its KTJ Project in Timor-Leste, aiming for a final investment decision by mid-2026 and first oil production by late 2027. Ownership of the Petrojarl I FPSO and strategic alliances underpin a fast-tracked development with forecast production of up to 30,000 barrels per day.

Anson Resources and POSCO Holdings have sealed a binding deal for a $7.2 million lithium extraction demonstration plant at Green River, advancing the project from concept to operational validation.

MRG Metals has verified substantial concentrations of valuable heavy minerals including monazite, rutile and zircon in alluvial deposits at its Adriano Rare Earth Project, with a total rare earth oxide content of 1.46%.

Nexsen has secured a strategic partnership with GHK Hospital Limited in Hong Kong, marking a significant step in validating and commercialising its rapid point-of-care diagnostics across North Asia.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.

Avira Resources has secured a two-year extension for its Mt Cattlin Gold Project tenure and is set to launch a 4,500-metre RC drilling campaign targeting a maiden resource estimate by year-end.

Santana Minerals has corrected its timeline for settling the purchase of 3,680 hectares for its Bendigo-Ophir Project, extending the deadline to the earlier of mid-2030 or 12 months after mining consents are granted.

Core Lithium has completed the second tranche of a A$120 million equity raise, securing A$67 million and shareholder approval for convertible notes, positioning the Finniss Lithium Project for continued development.

Amplitude Energy has received the VIC/L37 production licence for its Annie gas field, setting the stage for first gas in 2028 to supply Australia's east coast market.

Lindian Resources reports steady progress at its Kangankunde Rare Earths Project in Malawi, maintaining schedule for first production in late 2026 with key infrastructure and regulatory milestones achieved.