Latest Regulatory Approvals News

4DMedical reports a robust 56% revenue increase in FY2025, driven by SaaS expansion and strategic partnerships, while advancing FDA clearance for its innovative CT – VQ™ lung imaging software.

Atomo Diagnostics reported a 27% reduction in net loss to AUD 4.97 million for FY25, alongside a 7% revenue dip to AUD 3.79 million, driven by stronger margins and cost controls. The company also secured a significant US distribution contract through partner Lumos Diagnostics, positioning it for growth.

Immutep Limited reported a widened loss of A$61.4 million for FY2025, driven by increased R&D and clinical trial expenses, while progressing its lead immunotherapy candidate into a pivotal Phase III lung cancer trial. The company maintains a robust cash position supporting operations through 2026.

Mayne Pharma reported a 5% revenue increase to $408.1 million for FY25 but posted a net loss of $93.8 million, narrowing from the prior year. The company’s planned acquisition by Cosette Pharmaceuticals faces legal hurdles, delaying completion.

The Star Entertainment Group reported a challenging FY25 with a $471.5 million statutory net loss and a $77.1 million EBITDA loss before significant items, driven by regulatory reforms and market share declines. The group secured a $300 million strategic investment to support its turnaround efforts amid ongoing legal and licensing uncertainties.

The Star Entertainment Group reported a statutory net loss of $471.5 million for FY25, impacted by regulatory reforms and remediation costs, while securing a $300 million strategic investment to bolster liquidity.

Gladiator Resources has initiated the process to list on the US OTC Markets, aiming to enhance visibility and liquidity among North American investors as part of its rare earth elements growth strategy.

Broken Hill Mines Limited reported a $2.42 million loss for FY2025 amid a transformative acquisition of Broken Hill Mines Holdings Pty Ltd and a $20 million capital raise, marking its relisting on the ASX under the code BHM.

Next Science Limited reported a 7% revenue decline and a 20% reduction in net loss for H1 2025, alongside a major $50 million asset sale agreement with OSARTIS GmbH. The transaction, approved by shareholders, signals a strategic pivot for the biofilm-focused medical device company.

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.

PYC Therapeutics has reported promising safety data from the initial phase of its clinical trial for PYC-003, an RNA therapy targeting the root cause of Polycystic Kidney Disease. The findings, presented at the ANZSN conference, highlight the drug’s tolerability in healthy volunteers, paving the way for further clinical development.