Compass Pathways: Phase 3 COMP006 meets primary endpoint; COMP360 25mg shows -3.8 point MADRS reduction (p<0.001)

COMPASS Pathways plc

COMP006: Two 25mg doses vs 1mg showed -3.8 point MADRS reduction (p<0.001) at Week 6, meeting primary endpoint.
39% of COMP006 25mg arm achieved clinically meaningful reduction (≥25% MADRS) at Week 6.
COMP005 single dose previously showed -3.6 point difference (p<0.001); durable effect through Week 26 after 1-2 doses.
Safety profile: TEAEs mostly mild/moderate, resolving within 24h; SAE suicidal ideation <1% across both trials.
Company requested FDA meeting to discuss rolling NDA submission for COMP360 in treatment-resistant depression.

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