Compass Pathways Said Its Accelerating Commercialization Readiness Plans By 9-12 Months. It Has Completed COMP006 Trial Enrollment And Meeting With FDA On Marketing Application Submission Strategies For COMP360 In Treatment Resistant Depression, Including Potential Rolling Submission

Author: Benzinga Newsdesk | November 04, 2025 06:38am

COMP360 psilocybin treatment in TRD (Treatment Resistant Depression)

• Second Phase 3 trial, COMP006, has completed enrollment (n=585)
• In June 2025, we announced achievement of the 6-week primary endpoint in the first of two phase 3 studies (COMP005), where a single administration of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity at six weeks and no unexpected safety findings
• Positive Type B meeting with the FDA in September 2025 to discuss the Company's NDA submission strategy for COMP360 in TRD and potential acceleration scenarios, including rolling submission
• Second phase 3 trial (COMP006) 9-week (Part A) data and COMP005 26-week (Part B) data are expected in Q1 2026
• 26-week (Part B) data from COMP006 is expected in early Q3 2026

Posted In: CMPS