Latest Regulatory Milestones News

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Syntara Limited has unveiled encouraging interim Phase 2a data for SNT-5505, an add-on therapy targeting myelofibrosis patients with suboptimal response to ruxolitinib. The data highlight meaningful symptom relief and spleen volume reduction, positioning the drug as a potential game-changer in a challenging treatment landscape.

Renascor Resources has received provisional development authorisation from South Australia’s Minister for Planning to build a commercial-scale battery anode material plant, marking a pivotal step in its vertically integrated graphite project.

PointsBet Holdings has secured Foreign Investment Review Board approval for MIXI Australia's proposed full acquisition, marking a key regulatory milestone in the takeover process.

Southern Palladium has raised A$8 million through a strategic placement to accelerate its Definitive Feasibility Study and staged mine development at the Bengwenyama PGM project, backed by a major cornerstone investor.

Pure Hydrogen Corporation has secured a 15-year Potential Commercial Area approval and extended its ATP 927 permit for the Windorah Gas Project, marking a critical regulatory milestone ahead of its planned spinout.

Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.

Lotus Resources has secured Environmental and Social Impact Assessment approval for its Kayelekera Uranium Project in Malawi, paving the way for uranium production to resume in the third quarter of 2025. The company also completed a key board transition, signaling a new phase in its governance.

Chimeric Therapeutics has secured FDA Fast Track designation for its CHM CDH17 CAR-T therapy targeting gastroenteropancreatic neuroendocrine tumours, accelerating its path toward regulatory approval and patient access.

Recce Pharmaceuticals has completed a A$15.8 million capital raise to fund pivotal Phase 3 clinical trials and progress its FDA application, positioning the company for potential commercial breakthroughs in antibiotic-resistant infections.

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.

Cardiex Limited has gained Therapeutic Goods Administration approval for its CONNEQT Pulse device, paving the way for commercial expansion in Australia alongside its established US presence.