Cybin Gets Breakthrough Therapy Designation For Its Psychedelic-based Therapeutic CYB003

(RTTNews) - Cybin Inc. (CYBN) Wednesday said that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its psychedelic-based therapeutic CYB003 for the treatment of major depressive disorder (MDD).

The company also announced data from the Phase 2 study showing that treatment with CYB003 in participants with MDD demonstrated robust and sustained improvement in depression symptoms. Seventy five percent of participants achieved remission and did not show signs of depression after treating with CYB003 for four months.

Data supports progression to a pivotal Phase 3 study of CYB003 in MDD in mid-2024, Cybin said.