• New 6-month data supports COMP360’s potential to establish a new standard of care in TRD
  • Data from positive COMP006 Phase 3 trial demonstrates durable benefit through at least 6 months further validating COMP360’s differentiated profile in highly chronic TRD
  • Across two highly statistically significant positive Phase 3 trials, COMP360 is the first classic psychedelic¹ to consistently demonstrate rapid onset, significant durability and reproducibility of effect in TRD, one of psychiatry’s most difficult conditions in which to demonstrate efficacy
  • COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings
  • Rolling NDA submission and initial review underway and final submission expected to be completed in Q4
  • Commercial launch-readiness on track for end of 2026, with launch expected in first half of 2027
  • Compass continues to progress late-stage PTSD program, where millions of patients are urgently in need of new, effective options
  • Compass to host a webinar on July 7th at 8:00 am ET

Compass Pathways plc (NASDAQ:CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the 26-week results (Part B) from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which confirm COMP360’s rapid onset and durable profile. The 26-week 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.

The COMP360 Phase 3 program participants represent a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within the context of this severe population, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS2 (≥ 25%) by week 6, following two fixed doses of COMP360, and maintained durable response at least through Week 26. This 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. 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.

A rolling New Drug Application (NDA) submission and initial review with the U.S. Food and Drug Administration (FDA) is underway and final submission remains on track to be completed in Q4, 2026. Compass anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling.