Bloomberg Businessweek New Hope for People Battling With Depression
Dec 8, 2025
Kabir Nath, CEO of Compass Pathways, leads the charge in developing COMP360 psilocybin therapy for treatment-resistant depression. He discusses the resurgence of the psychedelics market and the promising results of their Phase 3 trials. Kabir shares insights on the regulatory landscape, detailing their engagement with the FDA and next steps toward market launch. He also addresses safety measures, potential applications beyond depression, and the company’s commitment to equitable access for patients. With a target of 3 million patients, the future of mental health treatment looks brighter than ever!
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Large Unmet Need In TRD
- Approximately 3 million U.S. patients live with persistent treatment‑resistant depression, and under 5% have medicines studied or approved for TRD.
- This represents a substantial unmet clinical and economic burden on patients and healthcare systems.
FDA Dialogue Enables Faster Path
- Compass aims to accelerate access to a psychedelic medicine for treatment-resistant depression by working closely with the FDA.
- They completed enrollment in their second phase‑3 study and expect primary data in Q1 next year to support accelerated approval.
Collect Robust Safety And Abuse Data
- Design rigorous trials and collect comprehensive safety and abuse‑potential data from the start.
- Track transient side effects and measures like 'liking' to demonstrate low abuse potential to regulators.