Overview
- The latest Phase 3 study found two 25 mg doses given three weeks apart produced a 3.8-point greater six-week reduction on the MADRS scale versus 1 mg.
- Compass reported the therapy was generally well tolerated across both late-stage studies with no new safety concerns identified.
- In June 2025, the first Phase 3 study reported a 3.6-point improvement after a single 25 mg dose.
- The company has requested a meeting with the U.S. Food and Drug Administration and said it plans to submit the therapy for approval later this year.
- Compass Pathways’ shares rose nearly 23% after the update.