Latest Regulatory Filings News

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

Wellnex Life reported an 18.2% sales decline in Q1 FY26 amid delayed IP licensing revenue and increased costs, while securing new debt facilities and exiting the medicinal cannabis segment.

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.

Fiducian Group Limited has voluntarily released its Appendix 4C for Q3 2025, reporting steady net inflows to its core platform and a rise in total funds under management to $15.6 billion.

Strike Energy Limited has addressed ASX concerns over a delayed filing of a director’s interest notice, attributing the lapse to administrative oversight while affirming confidence in its compliance processes.

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.

NSX Limited’s shares have been suspended from trading following Federal Court approval of its acquisition by an Ontario-based entity linked to CNSX Markets Inc. This marks a significant shift in ownership for the Australian stock exchange operator.

Aurumin Limited has sent out its Scheme Booklet detailing the proposed acquisition by Brightstar Resources, setting the stage for shareholder meetings in November. Securityholders are urged to review the materials carefully before voting.

Netlinkz Limited has attributed the late filing of a key director disclosure to an administrative error, while affirming its existing compliance frameworks remain robust.

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.