Latest Regulatory News

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.

Savannah Goldfields Limited is poised to restart gold production in 2025 at its Georgetown and Agate Creek sites, backed by solid ore reserves and ambitious exploration plans to extend mine life.

PointsBet Holdings Limited reported a 6% increase in revenue to $261.4 million for FY2025, alongside a significant reduction in net loss and its first full year of EBITDA profitability. The company’s Australian operations delivered record results while Canadian growth accelerated, setting a positive trajectory for the future.

AF Legal Group has reported a record-breaking FY25 with revenue up 27% to $27.6 million and a 77% jump in normalised profit before tax. The firm’s strategic acquisitions and operational improvements set a positive tone for FY26 growth.

AF Legal Group Ltd reported a robust 27% increase in revenue to $27.6 million for FY25, propelled by key acquisitions and operational expansion, despite one-off costs impacting statutory profits.

Dusk Group Limited reported solid financial growth for FY25, with revenue up 7.8% and net profit rising 5.5%, underpinned by strong online sales and strategic store expansions.

Novatti Group reports a record $51.8 million revenue for FY25 alongside a 65% improvement in underlying EBITDA, signaling a successful turnaround and a strategic pivot back to growth.

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.

Virgin Australia has reported a robust FY25 performance, surpassing IPO forecasts with strong earnings growth and operational improvements. The airline reaffirms its positive outlook for FY26, underpinned by fleet expansion and ongoing transformation benefits.

Memphasys Limited reported a net loss of AUD 4.94 million for FY25 while accelerating commercial efforts for its Felix System and advancing its RoXsta diagnostics platform.

PainChek Limited reported a 24% revenue increase to $4.8 million for FY25, narrowing its net loss by 7%, while progressing toward FDA clearance for its Adult PainChek App in the US and launching its Infant App in Australia.

Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.