Latest Regulatory Filings News

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.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Taiton Resources has issued nearly 1.8 million shares and close to 900,000 options to a sophisticated investor, part of an ongoing placement raising $125,000 so far. Additional shares and options will follow as funds come in.