Reporting by Josh Hardman and Noah Smith.

Nonprofit psychedelic research organisation Usona Institute has completed its submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) concerning its psilocybin candidate for major depressive disorder (MDD), Psychedelic Alpha understands.

It means it’s the second psychedelic NDA under review by the agency at present, after we reported that Resilient Pharmaceuticals (formerly Lykos Therapeutics ) refiled its MDMA for PTSD application in the summer . It also means that FDA could hand down a decision on a psychedelic application in late 2026, if the most optimistic timelines hold, or very early in the new year, given the fact that Usona, like Compass Pathways , is in receipt of a Commissioner’s National Priority Voucher (CNPV) that aims to return a decision to a developer within two months.

Here, we review the context surrounding Usona’s program and application, and what it might mean for its chief competitor, Compass, a for-profit…