Don't know if people know how noteworthy this is.
By completing their NDA submission ahead of $CMPS, the nonprofit Usona Institute could become the first to receive FDA Approval for a classic psychedelic treatment.
With the expectation of expedited review under Trump’s initiative, an FDA decision could conceivably arrive as early as late December depending on the timeline. The Commissoner’s National Priority Voucher (awarded to both Usona and Compass) targets reviews of just one-two months.
@Josh__Hardman had mentioned this possibility months ago too.
Curious whether we’ll get an update on Compass’s NDA during earnings tomorrow.
Psychedelic Alpha @Psyched_AlphaNonprofit 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. In our latest, we review the context surrounding Usona’s program and application, and what it might mean for its chief competitor, Compass, a for-profit psilocybin drug developer that is planning to submit its own NDA, for treatment-resistant depression (TRD), imminently. Read now on our website:
41163.3K



