Public backing fuels FDA hearing on psychedelic therapies and potential COMP360 approval

The FDA is holding a hearing on Monday to discuss the future of psychedelic drug development, after a wave of public comments expressed strong support for further research.

Analysts say the supportive ecosystem includes patients, clinicians, specialty psychiatry centers, the FDA, HHS, the White House and the VA, which could help bring new psychedelic medicines to market after 2027.

Compass Pathways' psilocybin-based depression candidate COMP360 is seen as the first possible launch, with expectations it could receive approval through the Commissioner’s National Priority Voucher program by the end of this year or early 2027. Jefferies analysts estimate a 75-85% chance of approval.