Latest Regulatory Submissions News

Anteris Technologies has enrolled the first patients in its pivotal PARADIGM Trial, testing the DurAVR Transcatheter Heart Valve against leading competitors in a global study.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

EMVision Medical Devices has expanded its pivotal clinical trial sites, secured a $3 million government grant, and raised $14 million through placement and share purchase plan, positioning itself strongly for upcoming regulatory submissions and commercialisation.

New Frontier Minerals reports significant progress in its Harts Range and NWQ Copper projects, revealing new heavy rare earth prospects and promising copper recovery results that could accelerate production timelines.

Avecho Biotechnology has raised $2.5 million from institutional investors to fast-track manufacturing and regulatory preparations for its CBD TPM capsule amid ongoing Phase III trials.

Imricor Medical Systems made significant regulatory strides with FDA submissions for its MRI-guided cardiac ablation devices and launched NorthStar commercially in Europe, even as it reported increased cash outflows in Q3 CY25.

TrivarX has completed recruitment of 60 patients in its US veteran-focused mental health trial, advancing validation of its novel single-lead ECG algorithm for depression screening. Positive interim results from 27 patients set the stage for full data release and commercial discussions.

Actinogen Medical has fast-tracked recruitment in its XanaMIA Alzheimer’s trial, closing pTau biomarker screening early and increasing participant numbers, aiming for final results by mid Q4 2026.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Immutep Limited’s Phase II trial of eftilagimod alfa combined with radiotherapy and KEYTRUDA in soft tissue sarcoma patients has exceeded its primary endpoint, showing a 51.5% median tumor hyalinization rate, more than triple the historical standard. These promising results, presented at ESMO 2025, suggest a potential breakthrough in a challenging cancer indication.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Immutep Limited has confirmed 30 mg as the optimal biological dose for its immunotherapy efti, following FDA approval of Project Optimus requirements. This milestone paves the way for the US launch of its pivotal Phase III lung cancer trial.