Latest Regulatory Milestones News

Argent BioPharma reports strategic cost-cutting moves including facility closures and delisting from the LSE, while securing German distribution approval and raising significant capital to support its drug pipeline.

Recce Pharmaceuticals has gained key regulatory and ethics approvals for its Phase 3 clinical trial in Indonesia and completed patient dosing for its Phase II trial, while securing a substantial A$6.75 million R&D tax rebate to bolster its financial position.

Avenira Limited finalised a $4.5 million strategic investment from Hebang Biotechnology and progressed key development milestones at its Wonarah Phosphate Project, signalling a focused push towards near-term production and long-term growth.

Genmin Limited has appointed a new CEO and Chair, improved its ESG rating to BBB, and made significant progress towards developing its Baniaka iron ore project in Gabon, targeting production in 2026.

Celsius Resources has obtained a six-month extension to meet funding conditions for its flagship MCB Project, while progressing engineering design and maintaining a stable cash position of A$1.053 million.

Galan Lithium Limited advances its Hombre Muerto West project with a new mining permit and a significant resource upgrade at Candelas, positioning itself among the global lithium leaders and targeting production in H1 2026.

Western Gold Resources Limited has secured expanded mining approvals, confirmed strong metallurgical recoveries, and updated its mineral resource estimate at the Gold Duke Project, positioning the company for a transition to production.

Prescient Therapeutics has secured FDA clearance for its PTX-100 Phase 2 trial targeting relapsed/refractory cutaneous T-cell lymphoma, while also appointing James McDonnell as its new CEO. The company reports steady progress in its cell therapy platforms and maintains a solid cash position bolstered by a recent R&D tax rebate.

Elsight reported a robust 32% increase in annual revenue for 2024, driven by a strategic pivot towards the defense sector, which now accounts for over half of its total revenue. The company’s expanding customer base and debt elimination position it well for growth in 2025.

Alligator Energy reports significant progress across its uranium portfolio, including regulatory milestones at Samphire and promising drilling results at Big Lake and Nabarlek North, supported by a solid cash position of $20.2 million.

Triton Minerals has secured A$17 million from the sale of a 70% stake in its Mozambique graphite assets, while progressing environmental approvals and unveiling promising high-grade gold and copper results at its new Aucu project.

Echo IQ confirms the material significance of its pre-submission FDA meeting for EchoSolv HF, marking a pivotal step toward US market entry and commercialisation.