Overview
- Compass Pathways reported that its 25 mg psilocybin dose met primary endpoints in two Phase 3 trials, with 25% of patients responding at six weeks in COMP005 and 39% in COMP006.
- The company said the therapy was generally well tolerated, with most adverse events mild to moderate and resolving within 24 hours.
- The second trial included a 1 mg active-control arm designed to reduce functional unblinding that can skew psychedelic studies.
- Investigators reported some patients improved within a day and that benefits from one or two doses lasted at least 26 weeks for a subset of participants.
- Compass has requested an FDA meeting and plans a Q4 2026 submission, while shares rose about 24% this week as uncertainty persists following reports of a prior veto of accelerated review.