Latest Regulatory Engagement News

Entropy Neurodynamics reports encouraging early clinical results from the first patient treated with TRP-8803, an IV-infused psilocin therapy for Binge Eating Disorder, showing improvements across multiple symptom areas.

Insignia Financial’s Funds Under Management and Administration edged up to $342 billion, driven by strong inflows into its Wrap platform and multi-asset solutions, while Master Trust funds faced ongoing outflows amid product transitions.

NobleOak Life Limited has increased its stamp duty provision to $6.5 million following a dispute with the Victorian State Revenue Office over exemption eligibility, prompting pricing changes and ongoing regulatory engagement.

NeuroScientific Biopharmaceuticals reports encouraging clinical responses in fistulising Crohn’s disease patients treated under Australia’s Special Access Scheme, setting the stage for pivotal Phase 2 trials later this year.

AdAlta Limited has raised A$1.2 million through a strategic placement to advance its innovative PD1 armored MSLN CAR-T therapy for solid cancers, reinforcing its unique 'East to West' cellular immunotherapy approach.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Western Gold Resources has approved the Decision to Mine for its Gold Duke Project, marking a key shift from exploration to production with first gold targeted in early 2026.

Atlantic Lithium has submitted a revised Mining Lease for its Ewoyaa Lithium Project to Ghana's Parliament, incorporating updated royalty rates aligned with new legislation. The lease awaits parliamentary ratification amid evolving fiscal terms.

Boss Energy has withdrawn its 2021 Enhanced Feasibility Study for the Honeymoon uranium project due to significant deviations in resource assumptions, launching a new study focused on a wide-spaced wellfield design that could lower costs and improve recoverability.

Neurotech International has locked in $4 million through a share placement to advance its promising paediatric neurological drug, NTI164. The raise, supported by both new and existing investors including company directors, aims to fund critical clinical and regulatory milestones.

Finder Energy has completed the acquisition of the Petrojarl I FPSO, gaining full control of vital infrastructure for the Kuda Tasi and Jahal project and setting the stage for a Final Investment Decision by mid-2026.