Latest Regulatory Filings News

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Cambium Bio has secured a strategic partnership with French pharmaceutical leader Benta SAS to commercialise its regenerative dry eye treatment, Elate Ocular, across Europe and the Middle East. This follows a second platelet-lysate licensing deal within days, underscoring growing industry confidence in Cambium’s platform.

Great Northern Minerals Limited has addressed an ASX query regarding the delayed filing of director interest notices, attributing the lapse to an administrative oversight related to option expiry. The company reassures investors that compliance frameworks remain robust.

Dotz Nano has responded to an ASX price query following unusual trading activity, confirming no undisclosed information and reaffirming compliance with continuous disclosure rules.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

LTR Pharma Limited (ASX, LTP) reported significant progress in FY25, advancing its novel intranasal treatments for erectile dysfunction and expanding its commercial footprint in Australia and the US. The company secured key partnerships and capital raises, positioning itself for regulatory milestones and global market entry.

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

Aspermont Limited has announced a Share Purchase Plan offering eligible shareholders the chance to buy new shares at a discounted price, aiming to raise up to $1.25 million. The offer opens on September 1 and closes mid-month, with trading expected to start by September 19.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.