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Compass Pathways Says It Achieved Primary Endpoint In Ongoing Phase 3 COMP006 Trial, The Second Of Two Phase 3 Trials Of Two Fixed Doses Of COMP60 Psilocybin For Treatment-resistant Depression

Benzinga·02/17/2026 11:35:38

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Two highly statistically significant positive Phase 3 trials confirm highly differentiated profile for COMP360, demonstrating a level of clinical effect that has historically been extremely difficult to achieve in TRD
COMP360 is the first classic psychedelic1 to consistently achieve a highly statistically significant result and clinically meaningful effect, with a generally well-tolerated and safe profile
In COMP006, two doses of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS2 with a mean difference of -3.8 comparing 25 mg to 1 mg (p<0.001)3
Clinically meaningful reduction in MADRS (≥ 25%) observed in significant number of participants in 25mg arm of both trials with 25% in COMP005 and 39% in COMP006
Statistically significant rapid onset from the day following administration maintained at all measured timepoints through Week 6 in both clinical trials in the 25 mg arm
In COMP005, participants who achieved a clinically meaningful reduction in MADRS at Week 6 with COMP360 25 mg maintained durability of effect at least through Week 26 after just one or two doses
Across both Phase 3 trials to date, COMP360 is demonstrating a generally well-tolerated and safe profile with no unexpected safety findings
Compass has requested a meeting with the FDA to discuss a rolling submission and review and expects to complete an NDA submission in Q4