Latest Regulatory Submissions News

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.

Imricor Medical Systems saw a sharp 69.5% decline in revenue for 2025, driven by clinical trial impacts, yet narrowed its net loss to $25.3 million as it secured FDA clearance for key products post-year-end.

OncoSil Medical has reported record dose sales and cash receipts in the first half of FY26, supported by encouraging clinical trial results and expanded European market penetration.

Orthocell Limited has reported a record half-year revenue of $6.2 million, driven by accelerating sales of its regenerative medicine products and expanding global footprint. The company’s US commercial launch of Remplir™ is gaining momentum alongside new market entries in Canada, Hong Kong, and Europe.

Vysarn Limited has reported a record first half for FY26 with revenue hitting $66.8 million and NPBT nearly doubling year-on-year to $10 million. The company reaffirms its full-year $20 million NPBT target, supported by strong industrial and advisory segment growth despite timing challenges in technology projects.

BPH Energy Ltd reported a half-year net loss of $925,691, weighed down by investment write-downs and associate losses, while raising $1.2 million to fund exploration and development. The company’s future hinges on a Federal Court review of a critical offshore permit held by investee Advent Energy.

Nexalis Therapeutics has completed a key capital raising milestone, issuing new shares, options, and performance rights following shareholder approval. This move supports the company’s clinical-stage drug development programs targeting pain and mental health.

Native Mineral Resources has successfully poured 1,543 ounces of gold doré at its Blackjack Processing Plant, while progressing key operational and regulatory initiatives to optimise mining and processing activities.

Patrys Limited has appointed Dr Samantha South as its new CEO, aiming to leverage her biotech expertise to fast-track clinical development and commercialisation of its therapeutic antibody pipeline.

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.

Memphasys has raised $800,000 through a share placement to accelerate the commercial expansion of its Felix™ System, following key regulatory approvals and initial revenue milestones.