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Compass Pathways Completes COMP360 Psilocybin New Drug Application to U.S. FDA for Treatment-Resistant Depression

CMPS
  • Compass Pathways submitted a robust New Drug Application (NDA) to the U.S. FDA for COMP360 psilocybin, its synthetic formulation for treatment-resistant depression (TRD).
  • The submission is supported by data from two Phase 3 trials and one Phase 2b study, all of which met their primary endpoints.
  • The clinical programs involved more than 1,000 participants living with highly chronic TRD.
  • Compass Pathways has established deep commercial capabilities to ensure successful launch execution & broad patient access.
  • The company targets a launch in the first half of 2027, subject to FDA approval.
  • COMP360 holds Breakthrough Therapy designation from the FDA & Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.
  • Approximately 4 million people in the U.S. live with TRD, yet fewer than 5% currently receive TRD-indicated treatment.
  • The drug contains a Schedule I controlled substance, requiring rescheduling by the DEA & states before commercialization in the U.S.
  • Compass Pathways is also executing a late-stage trial evaluating COMP360 for post-traumatic stress disorder (PTSD).
  • The press release includes forward-looking statements regarding regulatory review timing, potential accelerated approval, & commercialization risks.