Latest Regulatory Engagement News

Predictive Discovery Limited and Robex Resources have announced a merger to create a leading mid-tier gold producer in West Africa, targeting over 400,000 ounces of annual gold production by 2029. The combined entity, MergeCo, will leverage advanced projects in Guinea and Mali, enhancing scale and capital market presence.

Syntara Limited has reported positive final data from its Phase 2a trial of amsulostat in myelofibrosis, demonstrating significant symptom relief and spleen volume reduction with a favorable safety profile. These results pave the way for advancing clinical development and partnership discussions.

Syntara Limited has reported encouraging Phase 2a results for amsulostat combined with ruxolitinib in treating myelofibrosis, demonstrating sustained symptom improvement and spleen volume reduction over 52 weeks.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Savannah Goldfields has secured crucial environmental approvals to restart gold production at its Georgetown Gold Project, with mining at Big Reef set to begin in October 2025. The company also received approval for a tailings storage facility expansion to support future processing.

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

St Barbara Limited reveals strategic progress on its Simberi Sulphide Expansion and Atlantic Projects, underpinning a robust production outlook and advancing key regulatory approvals.

Metals Australia Ltd reports key milestones in its Lac Carheil Graphite Project, achieving battery-grade spherical graphite purity and selecting Sept-Îles as the preferred site for its Battery Anode Material plant.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Patriot Battery Metals has reached a significant milestone in the permitting process for its Shaakichiuwaanaan Lithium Project, with federal and provincial environmental assessments now aligned and progressing on schedule.

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.