Usona submits psilocybin NDA for major depressive disorder as its regulatory race with Compass Pathways reaches a critical stage

Usona Institute has completed submission of a new drug application to the U.S. FDA for its psilocybin candidate for major depressive disorder, making it the second psychedelic NDA currently under review. The filing could lead to an FDA decision in late 2026 or early 2027 because Usona has received a Commissioner’s National Priority Voucher intended to accelerate review. The development intensifies a closely contested race with for-profit developer Compass Pathways, which plans to submit its own psilocybin NDA for treatment-resistant depression imminently. Both programs have breakthrough therapy designation, rolling review, and priority vouchers, while FDA inspections and work on risk evaluation and mitigation strategies are underway. Usona may have a filing advantage, but Compass could retain strengths in trials, commercial infrastructure, and patents after approval.