Latest Regulatory Filings News

Titanium Sands Limited has lodged an Industrial Mining License application for its Mannar Heavy Minerals Project in Sri Lanka, marking a pivotal step towards production. The project boasts a substantial mineral resource and is progressing through environmental and feasibility milestones despite recent cyclone delays.

Arovella Therapeutics has taken a significant step forward by submitting an IND application to the U.S. FDA for its lead CAR-iNKT cell therapy, ALA-101, targeting blood cancers. This milestone paves the way for a first-in-human Phase 1 trial in both Australia and the U.S.

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.

Aurizon has lodged a proposed ten-year Network Access Undertaking with the Queensland Competition Authority, aiming to secure long-term certainty and enhanced operational incentives for the Central Queensland Coal Network.

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.

African Gold secures ASX waiver allowing cancellation of options without shareholder approval as part of Montage Gold acquisition scheme. This regulatory step smooths the path for the proposed takeover and option restructuring.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

Robex Resources and Predictive Discovery have amended their arrangement agreement, reducing the exchange ratio and delaying the shareholder meeting to late December. Major shareholders have recommitted to support the deal, which awaits court approval.

Winsome Resources Limited’s shares have been suspended from ASX trading following the company’s failure to respond to a critical price query within the requested timeframe. The suspension will remain until compliance issues are resolved.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.