COMP360 psilocybin - (COMP006)

July 7, 2026: Compass Pathways plc (NASDAQ: CMPS) reported 26-week (Part B) results from its ongoing Phase 3 COMP006 trial of COMP360 (synthetic psilocybin) in treatment-resistant depression (TRD), supporting rapid onset and durability of effect through Week 26 in a highly chronic TRD population (581 dosed across North America and Europe). COMP006 Part A (disclosed February 2026) met its primary endpoint at Week 6 with highly statistically significant, clinically meaningful results; separation between 25 mg and 1 mg arms was maintained through the blinded Part B period.

Efficacy highlights: 39% of participants in the 25 mg arm achieved a clinically meaningful MADRS reduction (≥25%) at Week 6 after two fixed 25 mg doses and maintained benefit on average through at least Week 26; retreatment in Part B was associated with nearly 30% of Week 6 responders later achieving remission (MADRS ≤12). The update also references prior Phase 3 COMP005 data showing durable response to at least 6 months after a single 25 mg dose.

Safety: generally well-tolerated with no new safety findings; most TEAEs were transient (often day of dosing). Common AEs included nausea, headache, anxiety, and visual hallucination; SAEs were 6.3% (1 mg) vs 5.7% (25 mg) over 26 weeks.

Regulatory/commercial catalyst: a rolling U.S. NDA submission is underway with FDA initial review; final NDA submission is expected to be completed in Q4 2026. Launch readiness is targeted for end of 2026, with a planned first-half 2027 launch subject to FDA approval and DEA rescheduling. A company webcast is scheduled for July 7 at 8:00 a.m. ET.