Compass Pathways: Stock Soars As Data Sets Up Psilocybin Approval Shot

Summary

• Compass Pathways plc surged over 40% after COMP360 met primary endpoints in a Phase 3 trial for treatment-resistant depression.
• COMP360 demonstrated rapid, durable efficacy and a favorable safety profile, but regulatory hurdles and rescheduling of psilocybin remain significant obstacles.
• Despite COMP360's potential, the competitive landscape, safety concerns, and uncertain reimbursement cloud the commercial outlook and timeline to approval.
• I maintain a Hold rating on CMPS due to high risk, funding needs, and the need for further data before reassessing the investment thesis.