Compass Pathways positive Phase 3 COMP005 psilocybin trial meets primary endpoint for TRD

COMPASS Pathways plc

COMP360 25 mg single dose showed MADRS reduction -3.6 vs placebo (p<0.001) at week 6.
DSMB chair: no new safety findings; no clinically meaningful imbalance in suicidality.
258 participants enrolled across 32 US sites; blinded extension to week 26, open-label to 52.
COMP006 (568 participants) 26-week data expected H2 2026; company plans FDA discussions.
First pivotal Phase 3 positive; supports regulatory path for COMP360 in treatment-resistant depression.

item 8.01

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