Latest Safety News

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Anson Resources has submitted a permit application for a production-scale disposal well at its Green River Lithium Project, marking a key step toward full-scale lithium production in Utah. This well will support both demonstration and future operations, enhancing geological understanding and resource modeling.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

Catalyst Metals Limited reported record FY2025 financial results driven by stable operations at the Plutonic Gold Belt and a buoyant gold price environment. The company plans to double annual gold production to 200koz through development of new mines and expanded exploration.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.

WestStar Industrial reports a 36% revenue decline and a $3.4 million net loss in FY25, driven by reduced activity at SIMPEC. New contract wins post-year-end signal a potential turnaround for FY26.

AVADA Group Limited reported a revenue decline and a $9.7 million impairment on its New Zealand operations in FY25, while completing Phase 1 of its business transformation including ERP implementation and operational consolidation.

Cycliq Group Limited reported a 3.8% revenue increase to AUD 4.78 million for FY2025 alongside a significant reduction in net loss, driven by strategic product enhancements and a new AI partnership. The company also strengthened its board and launched a revamped e-commerce platform, positioning itself for growth despite ongoing legal and operational risks.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.

Saferoads Holdings Limited reported a net profit of $4.35 million for FY2025, driven largely by a $5.27 million gain from the sale of its Road Safety Rental business. Continuing operations showed a modest loss amid a 14% revenue decline.

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.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.