Compass to Complete COMP360 FDA Filing Within Two Weeks as Usona Files First
- Compass Pathways expects to complete its rolling FDA submission for COMP360 in treatment-resistant depression within about two weeks, targeting a launch in the first half of 2027.
- Usona Institute reportedly filed an application for its psilocybin candidate in major depressive disorder on 2 November.
- Both programs hold national priority vouchers, which can cut review to one or two months.
💡 Points Based on public reports
The two filings aren't like-for-like: Compass's data come from a highly refractory population, while Usona's Phase 3 results are still undisclosed, so reviewers and prescribers will compare labels, not just speed. With vouchers, the first psychedelic approval could land within months, which moves the hard questions to administration logistics, monitoring requirements and payer coverage.
Compass to submit psilocybin depression drug for approval 'imminently' after stock wobbles ↗