Usona Files Psilocybin NDA, Accelerating Race Against Compass Pathways
Usona Institute has submitted a New Drug Application (NDA) to the FDA for its psilocybin candidate targeting major depressive disorder. This makes it the second psychedelic application under review, following Resilient Pharmaceuticals' MDMA filing. Both Usona and competitor Compass Pathways hold Commissioner’s National Priority Vouchers, potentially leading to FDA decisions by late 2026 or early 2027. While Usona has filed, Compass plans to submit its NDA for treatment-resistant depression this quarter. The race remains close, with both companies undergoing FDA site inspections and working on risk mitigation strategies.