Latest Regulatory Pathways News

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Cobre Limited has initiated an Environmental Impact Assessment and reported strong assay results from its Ngami Copper Project, setting the stage for a maiden Mineral Resource Estimate by August 2025.

Dundee Precious Metals Inc. (DPM) has announced a recommended acquisition of Adriatic Metals Plc, valuing the company at approximately USD 1.322 billion. The deal offers Adriatic shareholders a mix of cash and shares, representing a significant premium and marking a major consolidation in the precious metals sector.

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.

EVE Health Group has placed its first commercial purchase order for Dyspro™, a cannabinoid-based pharmaceutical targeting painful menstruation, signaling a key step toward market entry. The product is set for manufacturing and distribution within weeks, tapping into a rapidly growing global women’s health market.

Cobalt Blue Holdings has secured a three-year extension to its Major Project Status for the Broken Hill Cobalt Project, reinforcing its strategic importance to Australia’s critical minerals sector and enhancing development prospects.

C29 Metals has exited its Kazakhstan operations to focus on advancing its Mayfield Copper & Gold Project in Queensland, securing a three-year exploration license extension and confirming strong geological potential.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.