Latest Regulatory Filings News

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.

NSX Limited shareholders have overwhelmingly approved a scheme of arrangement for acquisition by a CNSX Markets-related entity, setting the stage for a significant market transition pending court approval.

Arafura Rare Earths has successfully raised $9.83 million through an upsized Share Purchase Plan, well above its $5 million target, boosting total capital raised this year to nearly $90 million.

The Royal Court of Jersey has approved Harmony Gold’s acquisition of MAC Copper, setting the stage for MAC’s trading suspension and delisting from ASX and NYSE.

Vonex Limited’s shares will be suspended from ASX trading following court approval of its acquisition by Maxo Telecommunications, marking a pivotal moment for the telecom services company.

One Click Group has locked in $1.25 million through a share placement, bringing Thorney Investment Group on board as a major shareholder and accelerating its Cash Advance product launch.

Linius Technologies has addressed a late filing of a director's interest notice, attributing the delay to an administrative oversight involving a new class of securities. The company has updated its processes and will re-brief directors to ensure future compliance.

Echo IQ reports a remarkable 153% increase in echocardiogram processing through its EchoSolv AS platform in the US, with a Mayo Clinic validation study nearing completion ahead of a critical FDA submission. The company is also advancing European market entry and strengthening its advisory team to accelerate global growth.

Orthocell has reported a record $3 million revenue for the September quarter, driven by strong sales of its nerve repair product Remplir™ in Australia and Singapore, with early US sales and Canadian market entry poised to accelerate growth.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.