Latest Regulatory Progress News

Orthocell Limited has posted a record quarterly revenue of A$2.73 million, driven by strong Australian sales of its nerve repair product Remplir™, with US market expansion poised to accelerate in FY26.

Santana Minerals has unveiled an updated Pre-Feasibility Study for its Bendigo-Ophir Gold Project, revealing lower capital costs, higher gold grades, and robust financial returns that position the project as a low-cost, high-margin operation in New Zealand.

Magnetite Mines has increased its Razorback Iron Ore Project resource estimate and is advancing strategic partnerships, while early saline water testwork shows promise for green iron production.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

Proteomics International has achieved a major milestone with the first worldwide patent granted in Japan for its PromarkerEndo blood test, designed to diagnose endometriosis early and accurately.

Invictus Energy advances its Cabora Bassa Project in Zimbabwe with an updated Petroleum Production Sharing Agreement draft and National Project Status approval, setting the stage for exploration drilling in 2025.

Neuren Pharmaceuticals has been granted a US patent for NNZ-2591 to treat Pitt Hopkins syndrome, bolstered by promising Phase 2 clinical trial results and FDA orphan drug status.

Predictive Discovery’s Definitive Feasibility Study for the Bankan Gold Project confirms robust economics with a 12.2-year mine life producing 250,000 ounces annually and a post-tax NPV of US$1.6 billion. The study outlines a clear path to construction and production in Guinea, backed by strong financial returns and environmental approvals.

Capricorn Metals has extended its mining contract with MACA Ltd for Karlawinda and named MACA preferred contractor for Mt Gibson, locking in cost certainty and supporting production growth.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

Credit Intelligence Ltd has agreed to sell its 60% stake in the loss-making subsidiary OneStep Information Technology Limited for a nominal sum, expecting a modest gain. This move aligns with its strategic pivot towards profitable ventures amid ongoing ASX suspension challenges.

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.