Latest Regulatory News

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Canyon Resources’ Definitive Feasibility Study confirms Minim Martap as a major bauxite project with a 33% ore reserve increase and robust economics, targeting production start in early 2026.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Dundee Precious Metals has received court sanction for its recommended acquisition of Adriatic Metals, paving the way for a scheme of arrangement expected to take effect on 3 September 2025. The transaction will result in Adriatic shares being cancelled and DPM’s listing on the ASX as a foreign exempt entity.

Warriedar Resources has secured a crucial ASX waiver allowing the cancellation of 5 million unlisted options without shareholder approval, smoothing the path for Capricorn Metals’ acquisition scheme.

Tamboran Resources has secured a pioneering approval from the Northern Territory Government to sell appraisal gas from its Beetaloo Basin exploration permits, marking a significant step toward local energy supply and revenue generation.

Corporate Travel Management Limited’s shares remain suspended on the ASX as the company delays lodging its Preliminary Final Report amid ongoing financial restatement concerns.

Hartshead Resources has struck a pivotal Well Carry Agreement with RockRose Energy, securing full funding for its Phase C drilling costs while trimming its joint venture stake. The move also triggers a licence extension application amid UK regulatory delays.

Elanor Investors Group advances its strategic alliance with Rockworth Capital Partners through a $125 million recapitalisation and Firmus acquisition, while rejecting an unsolicited takeover offer for its commercial property fund. The group also reports FY24 results highlighting stabilisation efforts amid high gearing.

Piedmont Lithium has completed its merger with Sayona Mining, creating Elevra Lithium, a major new player in hard-rock lithium supply for electric vehicles and energy storage.

SSH Mining Australia has entered a profit share mining agreement with High-Tech Metals to advance the Wagtail Gold Deposit, marking a pivotal step in the Mt Fisher Gold Project's development.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.