Latest Regulatory Affairs News

Aura Energy has postponed its strategic transaction for the Häggån project due to an ongoing Swedish government inquiry into alum shale mining and current market conditions, while retaining full ownership and commitment to the project.

Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.

Dimerix Limited has completed dosing of the last adult patient in its ACTION3 Phase 3 trial for DMX-200, exceeding its recruitment target and setting the stage for key regulatory milestones.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.

Island Pharmaceuticals has entered a pivotal research agreement with USAMRIID and the Geneva Foundation to accelerate FDA approval of Galidesivir for Marburg Virus Disease, leveraging top-tier US biodefense expertise.

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.