FDA Engagement and the Evolving Psychedelic Therapy Landscape: A Conversation 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 Spravato treatment sites now in place and increasing familiarity with REMS-based models, Nath emphasizes the importance of bringing forward additional options in the psychedelic space to address significant unmet need across MDD, TRD, and PTSD as psychiatry treatment paradigms continue to evolve.

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