09:28 AM EDT, 03/13/2024 (MT Newswires) -- Cybin ( CYBN ) said Wednesday that the Food and Drug Administration has granted breakthrough therapy designation to CYB003, its psychedelic-based drug to treat major depressive disorder.

The designation provides the drug with an expedited review pathway, as well as increased access to FDA guidance on trial design, the company said.

The designation follows a phase 2 trial that showed "robust and sustained improvement" in depression symptoms at four months, with 75% of patients in remission from depression after two 16mg doses, the company said.

A phase 3 study of CYB003 is to start in mid-2024.

The biopharmaceutical company also announced an oversubscribed private placement of 348,837,210 shares priced at $0.43 per share, a premium of about 17% over the company's 10-day volume weighted average price.

Gross proceeds are expected to be $150 million and to be used for phase 3 drug development for CYB003, working capital and general corporate purposes.

Cybin ( CYBN ) shares rose 25% in recent Wednesday premarket activity.

Price: 0.54, Change: +0.1, Percent Change: +23.66