Compass Pathways announced positive top-line results from its second Phase 3 trial (COMP006, N=581) of COMP360 psilocybin for treatment-resistant depression (TRD), meeting the primary endpoint with a 3.8-point greater reduction in MADRS scores at week 6 for the 25mg dose vs. 1mg control compared to the first trial's 3.6-point placebo-adjusted reduction.1356
Company shares spiked over 50% to nearly $9 on the news, rebounding from prior setbacks.15
Nearly 40% of high-dose patients achieved clinically meaningful depression score reductions, with rapid onset from day 1 lasting through six weeks; 26-week data from second trial expected Q3 2026.17
Compass plans a rolling FDA submission between October-December 2026, potentially making COMP360 the first classic psychedelic approved in the US; safety profile consistent with prior studies, no new concerns on suicidality.124
Analysts view data as sufficient for approval with robust uptake potential, though effect size described as modest rather than miraculous.126
Sources:
1. https://www.biopharmadive.com/news/compass-trial-data-fda-application-psilocybin-psychedelics/812332/
2. https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/
3. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx
4. https://ir.compasspathways.com/overview/default.aspx
5. https://www.fiercebiotech.com/biotech/compass-guides-psychedelic-therapy-second-pivotal-depression-win-triggering-filing-plan
6. https://psychedelicalpha.com/news/breaking-second-positive-phase-3-for-compass-psilocybin-though-modest-magnitude-raises-questions
7. https://www.psychiatrictimes.com/view/comp360-psilocybin-for-treatment-resistant-depression-achieves-primary-endpoint-in-phase-3-trial