Canadian psychedelic biotech company Cybin has received a breakthrough designation from the FDA for its lead candidate, CYB003, developed to treat major depressive disorder (MDD).

The CYB003 program is a deuterated psilocybin analog that showed promising results in a Phase II trial. The company plans to initiate Phase III clinical trials for the program by mid-2024. If the FDA grants approval, CYB003 would be the first adjunctive psychedelic-based therapy for managing MDD. 

Analyst QuickTake : Cybin's FDA breakthrough designation comes within a week of MindMed's breakthrough designation for its MM120 program targeting generalized anxiety disorder, marking rapid progress in psychedelic-assisted therapy. Both companies join industry counterparts Lykos Therapeutics (formerly MAPS) and Compass Pathways, which also obtained FDA breakthrough designations in August 2017 and October 2018 , respectively.