Compass Completes FDA Application for COMP360

LONDON / JERSEY CITY – Compass Pathways announced it has completed its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for COMP360, a synthetic psilocybin formulation, for treatment-resistant depression (TRD). If approved, COMP360 would become the first classic psychedelic medicine cleared by the agency.

The package includes two Phase 3 trials and a Phase 2b study. Each met its primary endpoint, and together they enrolled more than 1,000 people with long-running TRD defined by an inadequate response to at least two antidepressant courses.

The latest dataset arrived in July. In the second Phase 3 trial, COMP006, 39% of patients given a 25 mg dose twice reached at least a 25% improvement on a standard depression scale by week six, and the response held through week 26. Compass reported that adverse events were typically transient and occurred on dosing day.

The FDA granted a rolling review request and a Commissioner’s National Priority Voucher in April. The voucher shortens review from the usual 10 to 12 months to 1-2 months. Compass expects a launch in H1 2027, subject to approval. It also cautions that the voucher may not speed the process in practice and that the application must still meet the agency’s evidence standards.

A second gate sits outside the FDA. COMP360 contains a Schedule I controlled substance, and the DEA must reschedule it before any U.S. sale. On its first-quarter call, Compass said it would submit an Eight-Factor Analysis to FDA controlled-substance staff, followed by DEA review.

The filing follows a rough stretch for the stock. After multiple sources reported that Usona Institute had submitted its own psilocybin application, for major depressive disorder, Compass shares fell 28% and then partly recovered after earnings. RBC analysts said the market has room for more than one competitor. Stifel analysts noted that Usona’s Phase 3 data remain undisclosed, while Compass’s come from a highly refractory population.

Overall, this filing turns years of trial work into a regulatory record that reviewers, payers and policymakers can read. Three steps remain: FDA review, DEA rescheduling and state action. The voucher addresses the first. Compass’s own risk language lists the other two as open items with no fixed timeline. Even a clean FDA outcome would leave clinics, operators and investors watching the scheduling decision closely. Highly Capitalized Network-HCN will track each step.