Compass Pathways expects earlier FDA decision on psilocybin drug

Compass Pathways, which is developing a psilocybin treatment for severe depression, said Tuesday it now expects a potential approval decision from U.S. regulators in late 2026 or early 2027, nine to 12 months earlier than previously anticipated.

Following what it described as a “positive” meeting with the Food and Drug Administration, Compass is now planning for a rolling submission, in which it submits results of trials as they complete and the agency reviews the data as it receives them. If approved, Compass’ drug would be the first psilocybin therapy on the market. 

The FDA does not comment on meetings with drugmakers ahead of its decisions, but the expedited timeline appears to signal the agency’s interest in psychedelics. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have both voiced support for the development of the drugs, leading proponents to hope the agency will help get them on the market faster.