FDA Engagement and the Evolving Psychedelic Therapy Landscape: A Conversation with Compass Pathways CEO Kabir Nath

About this episode

The episode features a discussion on the FDA's approach to psychedelic drug development and its implications for the psychiatry landscape with Compass Pathways CEO Kabir Nath.

Recorded on 03/03/26 TD Cowen senior biotech analyst Ritu Baral speaks with Compass CEO Kabir Nath at TD Cowen’s 46th Annual Health Care Conference. Discussion focused on FDA’s current approach to psychedelic drug development, what it signals for the broader psychiatry landscape, and the evolving interventional psychiatry infrastructure in the community setting. Nath highlights a highly engaged and collaborative FDA Psychiatry Division, noting the agency's recent acceptance of 7-8 psychedelic therapy INDs, and its willingness to work constructively with sponsors despite relatively small datasets in early development. He highlights recent positive psychedelic clinical datasets as many traditional antidepressant approaches continue to fall short, including Compass’s successful Phase 2 and 3 TRD results across three standardized studies as evidence of the category’s clinical potential. The conversation also explores how the existing interventional psychiatry infrastructure in the community setting, shaped in part by the successful launch of Spravato, has transformed the field and lowered barriers for future commercial uptake of innovative psychedelic therapies. With 7200+ certified…

People in this episode

Host: Ritu Baral

Guest: Kabir Nath

Topics covered

• psychedelic therapy
• FDA drug development
• psychiatry landscape
• clinical trials
• interventional psychiatry
• mental health treatment

Keywords

• psychedelic therapy
• FDA
• Compass Pathways
• clinical trials
• mental health
• interventional psychiatry
• Spravato
• TRD
• MDD
• PTSD

Mentioned in this episode

Organizations: Compass Pathways, FDA, TD Cowen, Spravato, FDA Psychiatry Division

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