Latest Regulatory Affairs News

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.

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.