Cybin receives FDA Breakthrough Therapy Designation for CYB003

Cybin announced that the FDA has granted BTD to CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of MDD. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD. The company also announced that its Phase 2 trial of CYB003 in MDD demonstrated robust and sustained improvement in depression symptoms at four months with 75% of participants receiving two 16mg doses achieving remission and no longer showing signs of depression. These significant milestones reflect the company’s commitment to advancing cutting-edge treatment options for MDD, marking a transformational moment in the pursuit of regulatory approval.