
Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD).
The company had previously been granted approval for the study from the Institutional Review Board, a group that works under FDA regulations. The IND acceptance, though, constitutes a milestone as it will be the industry’s first novel psilocybin analog to enter clinical development.