At a Glance
- Company: Compass Pathways plc (NASDAQ: CMPS)
- Location: London, UK
- Headline figures: -3.8 MADRS points vs control at Week 6
- Focus area: Treatment-resistant depression (TRD)
- Next steps: FDA meeting for NDA submission
What happened?
Compass Pathways announced on 17 February 2026 that COMP360, its synthetic psilocybin therapy, met the primary endpoint in the Phase 3 COMP006 trial (n=581) for treatment-resistant depression. Patients receiving two 25 mg doses three weeks apart achieved a statistically significant -3.8 point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) versus 1 mg control at Week 6.
Why does it matter?
This second positive Phase 3 result in TRD—following COMP005’s single-dose win—positions COMP360 as potentially the first approved psychedelic therapy, offering rapid onset (day 1) and durability (up to 26 weeks) from one or two doses. It contrasts daily antidepressants and esketamine (Spravato), which requires frequent dosing, amid growing TRD need.
Who’s behind it?
Compass develops COMP360 with psychological support for psychiatric disorders; COMP360 has FDA Breakthrough Therapy designation for TRD. CEO Kabir Nath highlighted safety and response durability; 70% of COMP005 responders received second doses with sustained effects.
How was it achieved?
COMP006 used two doses to address durability; separation from control emerged day 1 post-dose, with consistent safety (no new signals). Effects persisted to Week 26 in long-term data, with 40% non-remitters remitting after retreatment. Low-dose control minimised unblinding risks.
What’s next?
Compass plans FDA Type B meeting for rolling NDA submission (potentially late 2026), targeting 2027 approval. Expansion to PTSD (FDA-accepted) and bipolar depression ongoing; commercial model emphasises clinic-based delivery.
What are people saying?
CEO Kabir Nath: “Safe to try… durable from one or two treatments.” Cantor analyst: “First psychedelic therapy approved by FDA, likely 2027.”