Latest Regulatory Milestones News

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Genmin Limited has successfully completed the first tranche of its capital raising, issuing over 131 million shares to fund its flagship Baniaka iron ore project in Gabon, targeting production by late 2026.

Magnetite Mines has cleared a crucial regulatory hurdle as its Razorback Iron Ore Project’s Mining Lease Proposal passes the South Australian Government’s validity assessment, paving the way for detailed technical review and public consultation.

Redcastle Resources and BML Ventures have submitted a critical Mine Development and Closure Plan for their Queen Alexandra and Redcastle Reef deposits, setting the stage for gold production to commence in early 2026.

Santana Minerals has secured formal acceptance from New Zealand's Environmental Protection Authority for its Fast-track Approvals application, moving the Bendigo-Ophir Gold Project closer to construction.

Island Pharmaceuticals has secured membership in the Medical Countermeasures Coalition, positioning its antiviral Galidesivir for critical US government stockpiling and regulatory milestones.

Southern Palladium fast-tracks development at its Bengwenyama PGM Project, advancing drilling and infrastructure plans while securing key regulatory approvals.

Estrella Resources reports strong progress at its Werumata Limestone Project with over 70% of drilling completed, alongside promising manganese intersections at Ira Manganese Prospect. Infrastructure and feasibility studies are underway, positioning the company as a first mover in Timor-Leste’s emerging mining sector.

The Star Entertainment Group has secured crucial regulatory approvals to convert a $300 million strategic investment by Bally’s Corporation and Investment Holdings into equity, setting the stage for board changes and a path toward financial recovery.

Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.

HeraMED has achieved a significant regulatory milestone with the Therapeutic Goods Administration upgrading its HeraBEAT fetal heart rate monitor to Class IIb, making it the only remote home-use device approved in Australia. This positions the company for a potentially lucrative expansion in the Australian maternity care market.

Bio-Gene Technology Limited updates on its development of two novel insecticides, Flavocide and Qcide, highlighting regulatory progress, commercial partnerships, and a strong market outlook across multiple sectors.