Compass Pathways' Psilocybin Therapy Achieves Key Phase 3 Milestone

Compass Pathways has announced that its investigational psilocybin therapy, COMP360, met the primary endpoint in its Phase 3 COMP005 trial for treatment-resistant depression (TRD). The study demonstrated a statistically significant 3.6-point reduction in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo after six weeks .

Despite this clinical success, investor response was muted, with shares declining amid concerns over the lack of detailed data and the impact of regulatory scrutiny on psychedelic treatments. The FDA's recent rejection of a similar therapy due to issues with functional unblinding has heightened caution in the sector .

COMP360, a synthetic formulation of psilocybin, has received Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK. Compass Pathways plans to present these findings to regulatory authorities while awaiting results from its second pivotal trial, COMP006, expected in the second half of 2026 .