Latest Regulatory Submissions News

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.

Tetratherix Limited has raised approximately $5 million to fast-track its Tutelix prostate spacer into pivotal clinical trials across Australia and the US, aiming to improve radiation therapy for prostate cancer patients.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Viking Mines has successfully identified multiple new high-priority tungsten targets at its Linka Project in Nevada through cutting-edge gravity and magnetic surveys, prompting an expanded exploration program.

Greenwing Resources has updated its Que River Project scoping study, reflecting a sharp rise in metals prices that boosts projected cash flows to nearly double previous estimates. The company is advancing regulatory approvals and exploring strategic partnerships to capitalise on these improved economics.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Bio-Gene Technology Limited reports strong progress in toxicology studies for Flavocide, targeting its first regulatory submission in Australia by March 2027. This milestone sets the stage for global registrations of the novel insecticide with a new mode of action.

Avecho Biotechnology has completed recruitment for the interim analysis cohort of its pivotal Phase III trial for a CBD insomnia treatment, with results expected in June 2026. This milestone could significantly de-risk the program and unlock major market opportunities.

Avecho Biotechnology reported a 9.3% revenue increase alongside a 41.5% rise in net loss for 2025, while progressing its Phase III CBD insomnia trial and securing a significant licensing agreement with Sandoz.

Paradigm Biopharmaceuticals reports a sharp rise in half-year losses as it intensifies investment in its pivotal Phase 3 trial for knee osteoarthritis, setting sights on a critical interim analysis in mid-2026. The company also expands its osteoarthritis pipeline and maintains strong funding amid a strengthening biotech sector.

Neurotech International reports a dramatic reduction in half-year losses alongside significant clinical and regulatory progress for its lead cannabinoid therapy NTI164. The company also strengthens its cash position through a $4 million placement and a $4.7 million R&D tax refund.

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.