Compass Pathways reports positive 26-week Phase 3 COMP006 data for COMP360 in TRD; NDA on track for Q4 2026

COMPASS Pathways plc

• 39% of 25 mg arm achieved ≥25% MADRS reduction at Week 6, maintained through Week 26.
• Retreatment in Part B enhanced benefit: nearly 30% of responders at Week 6 later achieved remission.
• Safety profile generally well-tolerated; SAEs similar across arms (6.3% vs 5.7%).
• Rolling NDA submission with FDA on track for Q4 2026; launch anticipated H1 2027 subject to approval and DEA rescheduling.
• COMP006 enrolled 581 participants with highly chronic TRD (average depressive episode >3 years).