COMP360 psilocybin - (COMP005)

September 9, 2026: Compass Pathways plc (NASDAQ: CMPS) reported topline 52-week open-label Part C results from the Phase 3 COMP005 trial of COMP360 (synthetic psilocybin) in treatment-resistant depression. In participants originally randomized to 25 mg who received an additional open-label 25 mg dose in Part C, MADRS improved by an average 13 points from baseline at Week 52, suggesting added benefit and durability through 1 year. In participants originally randomized to placebo who received their first 25 mg COMP360 dose in Part C, MADRS improved by an average 10 points from baseline by the end of Part C, supporting rapid onset and durable effect from a single dose.

Across all Part C participants receiving open-label 25 mg COMP360, response rates were 40%-45% and remission rates were about 30% from Day 1 through Week 6 post-dose. Safety in Part C was consistent with Parts A and B, with no new safety signals.

The company said a rolling NDA submission and review are underway, with final submission on track for Q4 2026, and it continues to expect a commercial launch in 1H 2027, subject to FDA approval. The ongoing pivotal Phase 3 COMP006 trial has enrolled 581 dosed participants and remains in Part C through Week 52.