Latest Regulatory Filings News

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.

StepChange Holdings has completed its acquisition of Perth-based ICT advisory firm BroadReach, significantly boosting its digital transformation and government consulting capabilities.

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.

RocketBoots Limited has responded to ASX concerns over a delayed director interest disclosure, attributing the lapse to an administrative oversight during a holdings restructure. The company affirms its compliance policies and has taken steps to prevent future delays.

Mount Hope Mining Limited has explained the late lodgement of director interest disclosures as an administrative oversight, responding to ASX concerns over potential compliance breaches.

Orthocell has reported a record $3.2 million in quarterly revenue, marking its seventh consecutive quarter of growth, driven by strong sales of its Remplir™ nerve repair product in Australia and early traction in the US 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.

Memphasys Limited has completed a $579K shortfall placement, boosting total funds raised to over $1.12 million to support the commercial rollout of its Felix™ System following recent regulatory approvals.

JAYRIDE Group has amended its quarterly cash flow report to correct classification errors, while outlining plans for a new SaaS platform rollout and potential capital raising to support operations.

Kingsgate Consolidated has secured a US$25 million standby loan facility with Nebari, significantly reducing its debt and improving financing terms. This move marks a major step in the company’s de-gearing strategy while maintaining funding flexibility.

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.