Compass Pathways publishes investor presentation on COMP360 psilocybin program, FDA filing progress and launch plans
Reuters2026/08/05 12:07- Compass Pathways outlined plans to file a rolling NDA for COMP360 psilocybin in treatment-resistant depression, targeting completion in Q4 2026.
- U.S. launch targeted for H1 2027, contingent on FDA clearance; Breakthrough Therapy designation cited alongside a Priority Review Voucher in TRD.
- Two Phase 3 trials, COMP005 and COMP006, met the primary endpoint on MADRS change at Week 6 with P<0.001.
- Company highlighted durability through 26 weeks with infrequent dosing; additional dosing described as deepening response in some patients.
- Commercial rollout planning centers on certified treatment sites, REMS readiness, specialty pharmacy or buy-and-bill distribution, payer engagement.
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