Today, psychedelic drug developer Cybin announced that it has received breakthrough therapy designation for CYB003, its deuterated psilocybin analog candidate under development for major depressive disorder (MDD).
As such, the company has become the fifth organisation to achieve FDA breakthrough therapy designation status for a psychedelic drug candidate. The announcement comes less than a week after MindMed announced that the FDA had handed it the designation for its LSD-D-tartrate candidate (MM120) in generalised anxiety disorder (GAD). (See FDA Hands MindMed’s LSD Candidate Breakthrough Therapy Designation in Generalised Anxiety Disorder; Company Provides 12-Week Data and Fleshes Out Phase 3 Program Plans.)
Cybin concurrently announced 4-month durability data from the optional open label period of the program’s phase 2 study, as well as a $150m private placement.
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