COMPASS Pathways, the leading company trying to turn psilocybin into a legal medicine, has not yet submitted the final paperwork the FDA (the US drug regulator) needs to approve it. Without that submission, approval before August 2026 is simply not possible. This matters because approval would be the moment when psilocybin therapy could legally move into clinics.
The leading psilocybin developer has no NDA at final decision stage; near-term approval is procedurally out of reach, making this a clean short-horizon falsifiable checkpoint for the sector's 'no hard catalyst' thesis.