Latest Regulatory Approvals News

Alterity Therapeutics has reported encouraging topline results from its open-label Phase 2 trial of ATH434 in advanced Multiple System Atrophy, showing slowed disease progression and biomarker stabilization.

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

Anax Metals has raised $3.3 million through convertible notes to push forward its Whim Creek copper-zinc project in Western Australia, while resolving a recent arbitration with its cornerstone investor Mineral Development Partners.

Bubs Australia Limited reports a strong FY25 with 29% revenue growth to $102.5 million, positive EBITDA turnaround, and sustained cash flow improvements. The company also advances its US market ambitions with a key FDA submission underway.

Morris Group has launched a conditional, non-binding takeover proposal for Reef Casino Trust, offering $3.70 per unit, rivaling the existing Iris bid. The Independent Board Committee urges unitholders to hold off while assessing this alternative.

UNITH Ltd reported a record quarterly cash receipt of $1.6 million in Q4 FY25, driven by strategic partnerships and platform innovations. The company is poised for growth with a new website launch and expanded European presence.

Blaze Minerals has acquired a commanding interest in the Loulombo Project in the Republic of the Congo, unveiling exceptional base metals grades and planning a maiden drilling campaign. Meanwhile, critical mineral discoveries in Uganda and a $2.42 million capital raise underpin its growth trajectory.

Charger Metals NL reported steady progress in its June 2025 quarterly activities, advancing lithium exploration at the Lake Johnston Project in Western Australia with funding support from Rio Tinto Exploration. The company awaits further drilling permits to continue testing promising targets.

Ionic Rare Earths’ Brazilian joint venture, Viridion, has advanced to the next phase of securing a substantial US$900 million funding package from Brazilian government agencies to develop rare earth refining and recycling facilities.

OD6 Metals has reported strong high-grade copper results from its maiden drilling at Gulf Creek, NSW, alongside progress in rare earth metallurgical testing and closure of a regulatory investigation.

Elanor Investors Group announces a $125 million strategic investment from Rockworth Capital Partners to stabilise its balance sheet and fund growth, including the acquisition of Singapore’s Firmus Capital.

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.