Compass Pathways: COMP360 shows rapid onset, durable 26-week benefit in Phase 3 COMP006; rolling NDA on track for Q4

Compass Pathways reported COMP006 26-week results showing rapid onset and durable clinical benefit of COMP360 in treatment-resistant depression and a rolling NDA submission on track for completion in Q4 2026.

Key Highlights:

• COMP006 Part B (n≈581 overall): 39% of 25 mg patients achieved ≥25% MADRS reduction by Week 6 and maintained benefit through Week 26.
• Retreatment enhanced outcomes: ~28% of initial responders who received retreatment later achieved remission in Part B.
• Safety consistent with prior trials: most TEAEs transient, day‑of‑dosing (nausea, headache, anxiety, visual hallucination); SAEs low and similar across 1 mg (6.3%) and 25 mg (5.7%) arms.
• Regulatory and commercial timeline: rolling NDA review underway; final NDA submission expected Q4 2026 and potential launch H1 2027, subject to FDA approval and DEA rescheduling.

Original SEC Filing:

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