Latest Regulatory Milestones News

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

BMC Minerals has cleared a major regulatory milestone for its ABM Mine in Yukon and reported thick, high-grade massive sulfide intercepts at its Krakatoa Zone, supporting resource expansion and a 2027 Final Investment Decision target.

QX Resources (ASX: QXR) secured all exploration licences for its Madaba Uranium Project in Tanzania, confirming high-grade surface uranium and advancing its 2026 exploration program with $1.23 million funding. Preparations are underway for a heli-borne survey and maiden drilling campaign.

De.mem Limited has extended its growth streak with record quarterly cash receipts of approximately $10.4 million, a 31% increase year-on-year, alongside positive operating cash flow of $504,000 for the March 2026 quarter.

MRG Metals’ joint venture partner Sinowin Lithium has delivered a comprehensive Environmental and Social Impact Assessment for the Corridor Central Titanium Dioxide project in Mozambique, marking a key regulatory milestone towards production in 2027.

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Ampol has increased its divestment offer to the ACCC by four additional sites, raising the total to 41 as it pushes to satisfy competition concerns in its EG Australia acquisition. The move aims to secure regulatory clearance ahead of a mid-2026 transaction close.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.

Paladin Energy has increased its FY2026 uranium production guidance at the Langer Heinrich Mine to 4.5-4.8 million pounds, driven by strong operational performance. Concurrently, the company secured environmental approval for its Patterson Lake South project in Canada, although a legal challenge looms.

South32's March quarter saw a tragic fatality at Worsley Alumina and weather disruptions, yet the miner delivered solid operational results and progressed its Hermosa zinc-lead-silver project. Production guidance was mostly maintained, with a notable revision lower for Australia Manganese due to water management issues.

Recce Pharmaceuticals has cleared a critical regulatory hurdle in Indonesia with a successful inspection of its Phase 3 clinical trial site for diabetic foot infections, paving the way for potential approval in 2026 amid a large and growing market.