Latest Regulatory Milestones News

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.

Chalice Mining’s Pre-Feasibility Study confirms the Gonneville Project as a globally significant palladium-nickel-copper mine in Western Australia, boasting robust returns and a rapid payback period.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Emerald Resources has secured mining approval for its Dingo Range Gold Project in Western Australia and completed a major accommodation camp, marking significant progress toward its goal of becoming a multi-mine gold producer.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

MGX Resources has received Foreign Investment Review Board approval to acquire a 50% interest in the Central Tanami Gold Project, marking a pivotal step toward becoming a long-life Australian gold producer.

Beetaloo Energy has secured crucial Federal Ministerial approval to sell appraisal gas from its EP187 exploration project, moving closer to final Northern Territory Government endorsement.