STAT+: Psilocybin data could be good enough for approval

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Source: STAT News

Original: https://www.statnews.com/2026/02/17/biotech-news-compass-psilocybin-data-for-fda...

Published: Tue, 17 Feb 2026 14:57:05 +0000

Compass Pathways has published the results of two Phase 3 studies for its psilocybin-based drug COMP360 in major depression. In both studies, patients who received the drug made greater improvements on depression measures than the control group. The company says the data supports FDA approval, although more detailed data are needed to assess patient benefits. COMP360 could be the first psilocybin product on the market and the second psychedelic after Johnson & Johnson's Spravato. Experts such as Jerry Rosenbaum of Massachusetts General Hospital said the data probably meets the requirements for approval, but is not miraculous. COMP360 is a synthetic formulation of psilocybin, previously investigated in the treatment of resistant depression.