Latest Regulatory Milestones News

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

Star Minerals has received mining approval for its Tumblegum South Gold Project, setting the stage for mining to commence in early 2026. With robust production targets and a key partnership in place, the project is poised to advance swiftly.

Memphasys Limited has restructured its leadership by eliminating the CEO role to back a direct-selling global commercialisation strategy for its Felix™ System, anticipating imminent CE Mark approval to enter the European IVF market.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

Terrain Minerals has completed a $1.42 million placement in December, topping up an earlier October raise to fully fund its upcoming drilling campaigns and maiden JORC resource estimate.

Beetaloo Energy has received a groundbreaking approval from the Northern Territory Government, enabling pilot gas production and sales from EP187 and advancing construction of the Carpentaria Gas Plant.

Race Oncology has raised $3.22 million through a private placement to fund its HARNESS-1 Phase 1a/b trial targeting non-small cell lung cancer, with patient enrolment expected early next year.

Snow Lake Resources has secured a crucial no objection from Australia’s Foreign Investment Review Board for its proposed acquisition of Global Uranium and Enrichment Limited, paving the way for the transaction’s next steps. The independent GUE board unanimously recommends shareholders back the scheme, pending expert endorsement.

Immutep has struck a strategic licensing deal with Dr. Reddy’s, granting rights to commercialise its novel cancer immunotherapy Eftilagimod Alfa across key emerging markets. The agreement includes a $20 million upfront payment and potential milestones exceeding $349 million.

Artrya Limited has landed a significant three-year commercial agreement with Northeast Georgia Health System, marking its second U.S. customer for the AI-powered Salix platform. This deal accelerates Artrya’s footprint in cardiovascular diagnostics across a major U.S. health network.

Meteoric Resources is poised for a critical environmental milestone as the Preliminary Environmental Licence for its Caldeira Rare Earth Project is set for approval at the upcoming COPAM meeting. This step could unlock the path to construction and keep the project timeline intact.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.