Latest Regulatory Approvals News

Cynata Therapeutics has completed the final patient visit in its Phase 3 trial for CYP-004, targeting knee osteoarthritis, with results expected in mid-2026. This milestone advances hopes for a disease-modifying therapy in a market desperate for new options.

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.

Macquarie Asset Management has tabled a $5.20 per share cash offer to acquire Qube Holdings, valuing the logistics giant at approximately $11.6 billion. The Qube board has entered an exclusivity agreement and signals unanimous support, pending due diligence and regulatory approvals.

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

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its clinical trial for PYC-003, an RNA therapy targeting Polycystic Kidney Disease. This milestone moves the drug closer to pivotal Phase 2/3 trials.

The a2 Milk Company has secured key regulatory approvals in China, moving closer to launching its infant formula products under the a2MC brand by mid-2027.

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.

Webjet Group has received a revised non-binding takeover offer from BGH Capital at A$0.91 per share, up from a previous A$0.80 bid, signaling renewed acquisition interest amid ongoing negotiations.

Bindi Metals Limited has announced a non-renounceable entitlement offer of options to raise approximately $46,000, underwritten by CPS Capital Group. The offer includes 46 million options to shareholders and 5 million options to the lead manager, with potential dilution if exercised.

Kore Potash has raised approximately US$12.2 million through a new share issue to fund critical project payments and maintain working capital for the next year. The fundraise also opens the door for major shareholders to increase their stakes, pending approvals.

St Barbara Limited reports solid progress on its Simberi Expansion Project and Atlantic 15-Mile Processing Hub, with key milestones reached and strategic options under review.

Cuscal Limited has received final regulatory approval from APRA for its full acquisition of Indue Limited, setting the stage for completion by early December.