Compass Pathways plc announced the successful achievement of the primary endpoint in the Phase 3 COMP006 trial, the second of two Phase 3 trials evaluating COMP360 for treatment-resistant depression, with highly statistically significant reduction in MADRS scores at Week 6 for 25 mg versus 1 mg doses. The company plans to meet with the FDA to discuss a rolling NDA submission expected in Q4.
Key takeaways
Successful primary endpoint achievement in Phase 3 COMP006 trial (N=581) on February 17, 2026
COMP360 25 mg vs 1 mg showed highly statistically significant MADRS reduction at Week 6 (p-value not fully specified)
25% of COMP005 participants achieved >25% MADRS reduction at Week 6 with durability to 26 weeks
39% of COMP006 participants achieved clinically meaningful MADRS reduction at Week 6
Over 1,000 participants across Phase 3 and Phase 2b trials; COMP360 generally well-tolerated
FDA Breakthrough Therapy designation; NDA submission planned for Q4