Latest Regulatory Filings News

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.

Dubber Corporation has secured a significant five-year contract with a leading North American telecommunications provider to deliver Mobile Voice Recording and AI-driven conversation analytics, marking a pivotal expansion in its global footprint.

Avecho Biotechnology is close to completing recruitment for the interim analysis cohort of its pivotal Phase III trial testing a CBD capsule for insomnia, with results expected in the first half of 2026.

Micro-X Limited has secured $6 million through a share placement to accelerate commercialisation of its innovative medical imaging technologies, with strategic partner Billion Prima increasing its stake to 8.5%. The capital raise supports key clinical trials and product development milestones.

Micro-X has raised $6.18 million through a placement that sees strategic partner Billion Prima increase its stake to 8.6%, funding key commercial and manufacturing scale-up initiatives in medical imaging.

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.

DataWorks Group signals a turning point with its strongest quarterly operating cash flow since refocusing on its core RegTech business, driven by key contracts in Australia and Ontario.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

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.

White Energy Company Limited has successfully closed a 5 for 12 entitlement offer, raising approximately $3.5 million before costs, with underwriter Morgans Corporate Limited covering the shortfall.

Alicanto Minerals has acknowledged a late filing of a director’s interest notice, attributing it to an administrative oversight. The ASX has queried the delay, prompting the company to review its disclosure procedures.