Latest Regulatory Approval News

Prescient Therapeutics (ASX:PTX) has opened a $7 million Share Purchase Plan at a significant discount to advance its lead cancer therapy PTX-100 beyond a pivotal Dose Optimisation Committee review in late 2026.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

Cavalier Resources has chosen SSH Group as its preferred mining contractor for the initial oxide pit at the Crawford Gold Project, aiming to kickstart mining operations within the next year.

HiTech Group has secured unconditional ACCC clearance for its acquisition of Hudson Global Resources’ Australian assets, removing a major regulatory obstacle ahead of completion.

Vysarn Limited reported a robust 31.5% increase in revenue to $140 million for FY2026, driven by strong performances across its industrial, advisory, and technology segments. The company is accelerating its national footprint with strategic acquisitions and progressing the Kariyarra Water Scheme.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

Racura Oncology's FY2026 results reveal a widening loss despite a 22% revenue dip, underpinned by significant scientific progress on its lead drug targeting the elusive MYC gene and a robust $34.3 million cash position.

Terragen Holdings posted a slight increase in net loss to AUD 3.75 million for FY2026, while advancing key commercial trials and securing a $7 million equity raise to fuel growth.

Nex Metals and its Aboriginal partner WTAC have applied for a 100ha lease to build processing infrastructure for the Kookynie Tailings Project, while metallurgical tests show promising gold recovery rates and potential tungsten by-product.

Piche Resources completed a $2.53 million entitlement offer, raising $728,324 from shareholders, with the underwriter stepping in to cover a $1.85 million shortfall. New shares and options are set to trade from 31 August 2026.

Aureka Limited has reported new high-grade gold intercepts extending mineralisation southwards at its St Arnaud Comstock project, reinforcing plans for near-term production using nearby milling capacity.

Australian Mines is poised to kick off a key drilling campaign at its Flemington Scandium Project, aiming to expand its already impressive resource and support plans to triple scandium production amid tightening supply.