Compass Pathways has presented durability data from its two pivotal Phase 3 trials (COMP005 and COMP006) showing that responders to its COMP360 psilocybin therapy maintained clinically meaningful antidepressant effects for at least 26 weeks after one or two doses in treatment-resistant depression (TRD). In COMP005, about 25% of patients on the 25 mg dose achieved and sustained a meaningful reduction in depressive symptoms through 26 weeks; in COMP006, a similar durable response was observed in roughly 39% of patients after two 25 mg doses. The company is on track to file a New Drug Application (NDA) with the FDA by the end of 2026, leveraging these durability findings and Breakthrough Therapy designation, with plans to be commercially ready in the U.S. by year-end.
Sources:
News Details - Compass Pathways - Investor Relations
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