Cybin (CYBN) said Thursday it has received approval from the UK Medical and Healthcare Products Regulatory Agency to begin its second phase 3 study evaluating CYB003, which is intended as an adjunctive treatment for major depressive disorder.

The phase 3 study, called EMBRACE, will enroll 330 patients suffering from moderate to severe major depressive disorder who are on a stable dose of antidepressant medication but are responding inadequately. It will be undertaken across the US, Europe and Australia, the company said.

The primary endpoint of the study will be a change in depressive symptoms from baseline at six weeks after the first dose.

Shares of Cybin rose more than 1% in recent premarket activity Thursday.

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