Compass Pathways hands FDA its psilocybin NDA for hard-to-treat depression

Compass Pathways plc said on Nov 9, 2026 that it completed its New Drug Application submission to the U.S. FDA for COMP360, its investigational synthetic psilocybin formulation, targeting treatment-resistant depression. The London-based biotech, which trades on Nasdaq as CMPS, describes the effort as the largest late-stage clinical program in psychedelic treatments. The filing sits under a rolling review, and the company has also been awarded a National Priority Voucher for COMP360 in TRD, which it expects could speed the FDA's review.

"People living with treatment-resistant depression have gone too long experiencing disproportionate suffering," said CEO Kabir Nath, thanking patients, families, advocates, researchers and clinicians who worked alongside the company. Nath said Compass is "leading the development of this new class of medicines with rigor and discipline" and is focused on getting COMP360 to patients as quickly as possible, subject to FDA approval. He added that the company has "a world-class and fully scaled commercial organization" ready to support broad patient access.

TRD is defined by an inadequate response to two or more courses of antidepressants at adequate dose and duration, setting it apart from major depressive disorder. Compass cites an estimated 4 million people in the U.S. living with TRD, fewer than 5% of whom are currently on a treatment indicated for the condition. A national survey of patients and caregivers found 95% of respondents described themselves as functioning but struggling, surviving day to day, or barely getting by, while roughly 70% of caregivers said TRD hurt the whole family's social, physical or mental health.

COMP360 already carries Breakthrough Therapy designation from the FDA and an Innovative Licensing and Access Pathway designation in the UK for TRD. Compass is also running a late-stage trial of COMP360 in post-traumatic stress disorder. One hurdle remains before any U.S. launch: COMP360 contains Schedule I controlled substances, so the Drug Enforcement Administration and individual states would need to reschedule it after any FDA approval.

The company, headquartered in London with a U.S. office in New Jersey, has said the pivotal Phase 3 program in TRD could support regulatory filings and approvals on an accelerated basis. Its own risk disclosures note that the rolling review and National Priority Voucher pilot may not actually deliver a faster FDA decision.