Compass Pathways (CMPS) is developing COMP360, a synthetic psilocybin for treatment-resistant depression, and plans to complete its FDA application by the end of the year, which could set up an approval decision in early 2027. After positive results in two Phase 3 trials, the FDA awarded COMP360 a Commissioner's National Priority Voucher (CNPV), which could shorten the review period to one or two months after filing. In 52-week results from the COMP005 trial, 40% to 45% of patients in the open-label extension saw at least a 50% reduction in depression symptoms, and about 30% achieved remission. With shares trading around $12, the average analyst price target of $23.75 implies about 95% upside. The article notes that approval is not guaranteed and that commercial adoption will depend partly on insurance reimbursement and the availability of treatment centers.
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