Latest Regulatory Submissions News

Argent BioPharma has signed a binding agreement to acquire AusCann’s 48% stake in CannPal, enhancing its clinical and intellectual property assets for CannEpil®. The deal includes an option for the Neuvis® drug-delivery platform and aligns with Argent’s U.S. dual-listing ambitions.

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.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

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.

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.

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.

St Barbara Limited has completed a compelling restart study for its Touquoy gold project in Nova Scotia, outlining a low-capital, near-term operation with robust economics and a positive permitting outlook.