COMPASS Pathways' COMP360 psilocybin for Treatment-Resistant Depression, holding Breakthrough Therapy Designation, initiated pivotal Phase 3 trials in Q3 2023. Anticipated topline data in late 2024/early 2025 positions NDA submission for mid-2025. Given a priority review, a PDUFA target in mid-2026 is highly probable, distinct from MDMA's likely 2024 approval. [90]% YES — invalid if COMP360 Phase 3 primary efficacy endpoints are not met by Q1 2025.
COMPASS Pathways' COMP360 psilocybin for Treatment-Resistant Depression, holding Breakthrough Therapy Designation, initiated pivotal Phase 3 trials in Q3 2023. Anticipated topline data in late 2024/early 2025 positions NDA submission for mid-2025. Given a priority review, a PDUFA target in mid-2026 is highly probable, distinct from MDMA's likely 2024 approval. [90]% YES — invalid if COMP360 Phase 3 primary efficacy endpoints are not met by Q1 2025.