Compass Pathways reports 26-week COMP006 data for psilocybin depression treatment

Compass Pathways plc disclosed on July 7, 2026 the results through 26 weeks (Part B) of its ongoing second Phase 3 trial, COMP006, testing COMP360, described as a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression, or TRD¹. The company said these findings, in nearly 600 patients build on previously reported results from the first Phase 3 trial, COMP005, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD.¹

The trial population was notably severe: the COMP360 Phase 3 program participants represent a highly chronic TRD population, with COMP006 participants having current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes.¹ In this population, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) (≥ 25%) by week 6, following two fixed doses of COMP360, and maintained durable response at least through Week 26.¹ The company noted this figure compares favorably to the 25% in COMP005 following a single dose, supporting the potential value of a second dose in enhancing clinical benefit for some patients.¹

On safety, COMP360 continues to demonstrate a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events (TEAEs) being transient and predominantly occurring on day of dosing.¹ Serious adverse events were similar across arms (6.3% in the 1 mg arm and 5.7% in the 25 mg arm) over 26 weeks but low overall across the trial.¹

Regarding regulatory timing, Compass said a rolling New Drug Application submission and initial review with the FDA is underway and final submission remains on track to be completed in Q4, 2026.¹ The company added that it anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration, or DEA, rescheduling.¹