Cybin Gets FDA IND Clearance For Phase 1/2a Trial Of CYB003 In Major Depressive Disorder

(RTTNews) - Cybin Inc. (CYBN) said Monday that it has received a "may proceed letter" and Investigational New Drug Application clearance from the U.S. Food and Drug Administration for its Phase 1/2a first-in-human clinical trial evaluating CYB003.

CYB003 is a proprietary deuterated psilocybin analog that is being developed for the potential treatment of major depressive disorder.

The company noted that it will begin recruiting patients immediately and expects to provide an interim pharmacokinetic and safety data readout in the fourth quarter of 2022.

In Monday pre-market trade, CYBN was trading at $0.65 up $0.06 or 10.64%.