Latest Regulatory Filings News

Recce Pharmaceuticals secured a non-binding term sheet with a major Middle Eastern pharma for its diabetic foot infection treatment and raised A$4 million to fund pivotal Phase 3 trials in Australia and Indonesia.

Orbminco has completed key drilling and metallurgical milestones at Majestic North, keeping its development timeline on track for a September Mining Development and Closure Proposal lodgement and final investment decision.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.

Lodestar Minerals has responded to an ASX query over the late filing of director interest notices, attributing the delay to an administrative oversight during an option conversion process. The company has updated its procedures to prevent future lapses.

EQT’s controlled entity has upped its non-binding offer for Perpetual to A$22.07 per share, a 2% premium on its initial bid. The proposal hinges on Perpetual’s Wealth Management sale and other conditions, with no certainty of a deal.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

Amaero has taken a key step toward listing in the US by confidentially submitting its draft registration statement to the SEC, though pricing and timing remain undecided.

Loyal Metals has cleared a key regulatory hurdle with ASIC registering the Scheme Booklet for its proposed A$0.45 per share acquisition by PT Bumi Resources. The Independent Expert endorses the deal as fair and reasonable, while Loyal’s board unanimously backs the scheme, setting the stage for a shareholder vote.

Mesoblast has completed treatment of 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain due to degenerative disc disease, with topline results expected mid-2027.

Kinetiko Energy is progressing rapidly from exploration to production with a major onshore gas discovery in South Africa, targeting first commercial compressed natural gas by late 2027 through a phased, capital-efficient development.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.