Latest Regulatory Filings News

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Resimac Group Ltd (ASX:RMC) has explained the late filing of a director’s change of interest notice as an administrative oversight and plans refresher training to reinforce compliance.

Dimerix will provide continued access to its investigational drug DMX-200 for eligible patients with focal segmental glomerular sclerosis after completing the pivotal ACTION3 Phase 3 trial, supporting ongoing treatment ahead of regulatory approval.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.

Taiton Resources has finalised a placement of 1.14 million shares at 7 cents each, including shares and options issued to insiders following shareholder approval.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

The Supreme Court of New South Wales has approved the scheme of arrangement for Rubik Australia to acquire Qube Holdings, setting the stage for trading suspension and ownership transfer.

Electro Optic Systems (ASX:EOS) has acknowledged a delayed disclosure of CEO Dr Andreas Schwer’s share rights and options, attributing it to an administrative oversight despite existing compliance protocols.

Telix Pharmaceuticals has gained FDA alignment to advance Part 2 of its ProstACT Global Phase 3 trial for TLX591-Tx in metastatic castration-resistant prostate cancer, setting the stage for U.S. enrolment pending regulatory approval.

Neurotech International has received Notices of Allowance from the USPTO for two patents covering its lead drug NTI164, reinforcing its intellectual property position as it advances Phase 3 trials for autism spectrum disorder.