Usona Files Its Psilocybin NDA for Depression, Tightening the Race With Compass
Psychedelic Alpha's Josh Hardman and Noah Smith report that the nonprofit Usona Institute has completed a new drug application with the FDA for its psilocybin candidate for major depressive disorder — reporting the outlet says it understands independently, since Usona itself declined to comment. That makes it the second psychedelic NDA currently before the agency, after Resilient Pharmaceuticals (formerly Lykos) refiled its MDMA-for-PTSD application this past summer.
Usona holds a Commissioner's National Priority Voucher, which the outlet says aims for a decision within roughly two months — pointing to a possible FDA call in late 2026 or very early 2027 — on top of the Breakthrough Therapy Designation and rolling review it already had. Per Psychedelic Alpha's sourcing, Usona is working with FDA on the agency's questions and on designing a risk evaluation and mitigation strategy, and the FDA has already inspected several Usona sites, including its Wisconsin headquarters.
Compass Pathways' COMP360, further along in some respects, is the other half of this race — Compass has guided that it will file its own treatment-resistant-depression NDA this quarter, and the outlet reports FDA site inspections of Compass began in September. A Compass quarterly update was due the day after this story ran. Psychedelic Alpha calls the two companies "neck and neck," with Usona holding "a slight edge" on filing timing for now, while noting Compass may still have advantages in the commercial steps between approval and launch. Our own trials tracker keeps both programs' trial-stage history in one place as this plays out.