Latest Regulatory Milestones News

Imugene has secured $11.12 million through a placement to advance its allogeneic CAR-T therapy azer-cel after early clinical data showed complete responses in BTKi-resistant lymphoma patients.

Noxopharm has taken a key regulatory step by requesting a pre-IND meeting with the US FDA for its autoimmune drug candidate SOF-SKN, aiming to smooth the path for clinical development and boost its commercial appeal.

GoldArc Resources has recorded its best grade control drilling results yet at the Mt Stirling Well deposit, reinforcing its resource model and advancing mine planning towards regulatory approval for mining commencement.

PainChek announces the immediate departure of CEO Philip Daffas, with COO Andy Hoggan stepping in as interim leader amid a strategic pivot to boost US market growth following FDA clearance.

Qube Holdings Limited will be removed from the S&P/ASX 200 Index before trading opens on July 9, 2026, following its pending acquisition by Rubik Australia, pending final court approval. Develop Global Limited will take its place in the index.

Racura Oncology has secured Bellberry HREC approval for its HARNESS-1 lung cancer trial, enabling expansion to additional Australian sites including Chris O’Brien Lifehouse and Austin Health, setting the stage for accelerated patient enrolment.

Gold Hydrogen gears up for critical Ramsay Project flow testing of Natural Hydrogen and Helium, while advancing a green methanol feasibility study with Mitsubishi Gas Chemical.

BCAL Diagnostics has acquired a 10.2% stake in Genetic Signatures for $1.39 million, aiming to merge early cancer detection with infectious disease diagnostics and expand its international footprint.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Native Mineral Resources (ASX:NMR) has cleared a key regulatory hurdle by submitting a Progressive Rehabilitation and Closure Plan for its Far Fanning Gold Project, while maintaining steady gold production at its Blackjack Gold Mine.

Capricorn Metals has gained crucial federal environmental approval for expanding its Mount Gibson Gold Project, clearing a key hurdle toward development commencement in late 2026.

GoldArc Resources has completed the first phase of a 34,000m grade control drilling program at Mt Stirling, delivering consistent broad mineralisation and higher-grade zones that underpin updated mine models ahead of regulatory approval.