FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement

Benzinga · Mar 13 23:33

Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.)

The news follows the same granted designation to MindMed's (NASDAQ:MNMD) LSD-derived treatment for Generalized Anxiety Disorder (GAD.)

Further, it makes the group of psychedelic-based treatments for mental health conditions that have in recent years received such status granted by the U.S. federal agency four therapies total: the mentioned two, plus MAPS' MDMA-assisted therapy for PTSD treatment and Compass...

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FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement

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