Latest Regulatory Affairs News

Island Pharmaceuticals reports a 213.8% increase in half-year loss to $4.81 million, driven by strategic acquisition and clinical development investments. The company advances its antiviral portfolio with Galidesivir and ISLA-101, supported by strong US regulatory engagement and a $9 million capital raise.

Imugene Limited reports a narrower half-year loss as it advances its promising azer-cel CAR T therapy with strong clinical results and FDA backing, supported by a $25 million capital raise.

Optiscan Imaging reports a sharp 43% drop in revenue and a 43% rise in losses for H1 FY26, driven by restricted research funding in key markets. The company bolsters its balance sheet with a $17.75 million capital raise to advance clinical studies and regulatory approvals.

Greenwing Resources has significantly enhanced the economics of its Que River Project following a sharp rise in key metal prices, nearly doubling projected cash flows and advancing a two-stage development plan.

BPH Energy and Bounty Oil & Gas have concluded their Federal Court hearing challenging the refusal to extend the PEP 11 permit, with the court's decision now pending.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Telix Pharmaceuticals delivered a strong 56% revenue increase in 2025, driven by U.S. sales of Illuccix and the launch of Gozellix, while advancing its therapeutic pipeline and expanding global manufacturing capabilities. Despite a net loss, the company is investing heavily in R&D and sustainability initiatives aligned with climate-related disclosures.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Aurizon Holdings reported a 9% rise in underlying EBITDA to $891 million for the half-year ending December 2025, driven by higher volumes and yields in coal and bulk segments. The company also raised its full-year dividend guidance and extended its share buy-back program.

Celsius Resources has secured a Supreme Court order validating its auditor appointment and prior share issues, paving the way for its shares to be reinstated on the ASX.

Algorae Pharmaceuticals has secured a key Licence & Supply Agreement with Cadila Pharmaceuticals to commercialise two generic cardiovascular and metabolic medicines in Australia and New Zealand, broadening its therapeutic reach beyond oncology.

Neuren Pharmaceuticals has received detailed feedback from the US FDA on its clinical development plans for NNZ-2591 targeting hypoxic ischemic encephalopathy and Pitt Hopkins syndrome, paving a clearer path forward despite some delays.