07:57 AM EDT, 08/26/2025 (MT Newswires) -- Cybin ( CYBN ) said Tuesday it has been granted approval in Australia to conduct the second pivotal study in its phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog for the adjunctive treatment of major depressive disorder.

The company said it received approval through the Clinical Trial Notification scheme, obtained clearance from multiple ethics committees of the Australian Therapeutics Goods Administration, and the study site Research Governance Offices.

Cybin ( CYBN ) said it has also received regulatory approvals to initiate the study in Ireland, Poland, Greece, and the UK. The drug candidate has also received Breakthrough Therapy designation from the US Food and Drug Administration for adjunctive treatment of Major Depressive Disorder, Cybin ( CYBN ) said.

The company said the study aims to enroll 330 participants at 60 clinical sites across the US, Europe, and Australia with moderate to severe major depressive disorder and whose symptoms are inadequately controlled with current antidepressants. Each study arm will evaluate two doses, administered three weeks apart, the company said.