Latest Regulatory Milestones News

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Cokal Limited has secured regulatory approval to resume mining at its Bumi Barito Mineral project, with operations set to restart mid-June and a 10,000 MT coal shipment planned for late June.

Sentinel Metals has kicked off its first diamond drilling campaign at the Columbia Gold-Silver Project in Montana, marking a major regulatory milestone and deploying a low-emission rig to test high-priority targets.

TechGen Metals has cleared the final regulatory hurdle to begin maiden diamond drilling at its Blue Devil Project in WA, targeting large-scale copper-gold systems with government co-funding easing exploration costs.

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.

Findi Limited has transitioned Stephen Benton to Non-Executive Chairman while Nicholas Smedley refocuses on the Indian business and TSI IPO plans. A strategic review aims to sharpen capital allocation and progress the Payments Bank licence.

Ardea Resources' Kalgoorlie Nickel Project – Goongarrie Hub has been awarded Lead Agency Status by the Western Australian Government, marking a key regulatory milestone that underscores its strategic importance in the critical minerals sector.

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.

Macarthur Minerals has approved a joint venture where Gold Valley assigns half its interest in the Lake Giles Ularring Hematite Project to Destec, bringing fresh operational expertise to the venture while Macarthur retains full ownership of its tenements.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.

PMET Resources has received a non-binding Letter of Interest from Société Générale to act as Mandated Lead Arranger for debt financing of the Phase 1 development of its Shaakichiuwaanaan lithium project in Quebec, advancing its syndicate-building strategy ahead of an updated feasibility study.