Compass hits primary endpoint in second Phase 3 psilocybin trial, giving it two positive pivotal studies

Compass Pathways plc (CMPS) — Compass Pathways announced that its Phase 3 COMP006 trial met its primary endpoint, with two fixed 25 mg doses of COMP360 psilocybin showing a highly statistically significant MADRS reduction versus a 1 mg comparator (difference of -3.8 points, p<0.001) at the Week 6 endpoint.

The company also released 26-week durability data from its first Phase 3 (COMP005), making COMP360 the first psilocybin therapy with two positive pivotal readouts in treatment-resistant depression. Compass reiterated plans to complete a rolling NDA submission in Q4 2026, and psychedelic stocks broadly rallied on the news.

Source: businesswire.com

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