Latest Regulatory Process News

Noxopharm says the FDA has supported its proposed Phase II design and chemical manufacturing strategy for SOF-SKN, its topical treatment candidate for cutaneous lupus erythematosus. The feedback improves regulatory clarity, but the trial remains targeted for the first half of calendar 2028 and is subject to further studies and regulatory requirements.

Finder Energy has extended the Kuda Tasi and Jahal project’s Final Investment Decision deadline to 30 November, after widening its international EPCI tender process. The company says debt financing is nearing its final stages, but the delay adds another checkpoint before its late-2027 drilling target.

Peter Warren Automotive has completed its acquisition of Wakeling Automotive, but the transaction remains tied to eight dealership divestments required by the ACCC. The deal expands Peter Warren’s dealership portfolio while leaving a significant regulatory obligation outstanding.

Yancoal Australia has secured NSW approval to continue mining at Hunter Valley Operations until the end of 2045, clearing a major regulatory hurdle after a six-year process. Federal environmental approval remains outstanding, with a deadline of 31 December 2026.

Hot Chili’s La Verde copper-gold discovery has expanded rapidly enough to become a cornerstone of the Costa Fuego project, while new funding gives the company room to pursue the next studies and permits. The key test now is whether drilling can translate into a maiden resource and a credible development case.

Adavale Resources has expanded its Parkes gold inventory to 383,300 ounces and consolidated a 610-square-kilometre position around London-Victoria and Calarie. The gains came alongside a larger annual loss, A$4.95 million in operating cash outflows and an auditor warning that future funding remains critical.

Lake Resources has reduced Kachi’s estimated capital cost by US$220 million and outlined a 25-year, 25,000-tonne-per-year operation. But the lithium developer still needs further funding, environmental approval, offtake and a final investment decision before construction can begin.

Catalina Resources has executed the mining lease transfer for its Nelson Bay River project, paving the way for up to $1.29 million in rehabilitation security to be recovered. The company plans to redirect the capital into November drilling at its Kirkalocka gold and Tallering tungsten projects, subject to final heritage clearance and regulatory steps.

Echo IQ says it sees a path to US FDA clearance for EchoSolv HF after receiving a Not Substantially Equivalent determination. The company is weighing an appeal, an Ombudsman review or a fresh 510(k) submission, but has not selected a route or set a firm timetable.

Green Technology Metals has completed the environmental assessment for its Seymour Lithium Project in Ontario, removing a major step from the mine’s permitting pathway. The milestone does not yet amount to final development approval, with a mine closure plan and several permits still required.

Zenith Minerals has acknowledged Forrestania Resources’ completed capital raising and acquisition of the Edna May Gold Project, but the takeover process remains subject to the Takeovers Panel’s final orders. Further disclosure from Zenith is still pending.

ADX Energy has lodged a third exploration permit application offshore Italy, expanding its Sicily Channel gas play footprint to around 1650 km2 amid encouraging geological assessments.