Compass Pathways accelerates psilocybin COMP360 launch timeline for TRD by 9-12 months after a positive FDA meeting

Psilocybin therapy COMP360 could reach the market up to 9-12 months earlier for treatment-resistant depression after Compass Pathways reports a “positive” September meeting with the FDA. Compass says the acceleration hinges on the FDA’s willingness to accept a rolling submission of its new drug application instead of waiting for the full package. The company also expects to read out data from its Phase 3 program ahead of schedule, which it believes could further support an earlier launch. The update is framed as a milestone for Compass’s commercial timeline for TRD, with CEO Kabir Nath characterizing the change as an acceleration of roughly nine months or more, conditional on regulatory review progress.