Compass Pathways Eyes Q4 FDA Filing After Two Positive Phase 3 Trials for Psilocybin in Treatment-Resistant Depression

Compass Pathways announced this week it is on track to complete its rolling New Drug Application (NDA) submission to the FDA by Q4 2026, following two positive Phase 3 clinical trials for COMP360 — its synthetic psilocybin therapy for treatment-resistant depression (TRD).

What the Trials Showed

COMP005 (reported June 2025) and COMP006 (reported February 2026) collectively enrolled more than 1,000 patients with treatment-resistant depression. Both trials met their primary endpoints. Results showed rapid onset of antidepressant effect — within 24 hours of a single supervised session — with durability extending to at least six months after one or two doses. Final 26-week durability data from COMP006 Part B are expected in early Q3 2026 and represent the last required dataset before NDA completion.

The FDA Fast-Track Context

An April 18 executive order directed the FDA to establish a National Priority Voucher pilot program for promising psychedelic compounds. Compass Pathways received one of those vouchers, which could accelerate post-filing administrative review to one to two months without changing the agency’s approval threshold. An NDA filing in Q4 2026 would put a potential approval decision in late 2026 to early 2027 — nine to 12 months earlier than the company’s previous guidance.

Why This Matters for People in Recovery

Treatment-resistant depression is among the most common reasons people with substance use disorders struggle to maintain recovery. Existing antidepressants often fail this population. If COMP360 receives approval, it would become the first psilocybin-based prescription medicine and open a new category of treatment for people for whom nothing else has worked. Find current treatment options at rizerecovery.com/find-help.