# COMPASS Pathways psilocybin therapy development > Live situation record from CLSTR: https://clstr.news/situations/compass-pathways-psilocybin-therapy-development > Updated: 2026-10-15T00:01:24.000Z. Sources: 5. Developments: 2. Biotechnology company COMPASS Pathways is advancing its lead candidate, COMP360, a synthetic psilocybin formulation designed to treat treatment-resistant depression. In mid-September 2026, the company reported a Q2 financial loss of $1.88 per share, missing analyst estimates, while noting that two Phase III trials had been completed with “highly statistically significant results.” By October 2026, the company moved toward a rolling FDA submission for COMP360, expected to be completed by the end of the quarter. Clinical data presented indicates that 25% of patients showed a clinically meaningful response after one session, rising to 40% after a second dose, with benefits potentially lasting up to a year. To support a potential commercial launch in 2027, CEO Kabir Nath indicated the company will adopt a “measured rollout strategy” to protect the broader psychedelic medicine sector. Preparations include developing a Risk Evaluation and Mitigation Strategy (REMS), investing in provider training, and engaging with the Centers for Medicare and Medicaid Services regarding reimbursement for clinical monitoring. ## Timeline ### 2026-10-15: Compass Pathways prepares FDA submission for psilocybin therapy Compass Pathways plans a cautious rollout for its synthetic psilocybin treatment, COMP360, following an expected FDA submission this quarter and a potential launch early next year. 3 sources. https://clstr.news/cluster/compass-pathways-prepares-fda-submission-for-psilocybin-therapy ### 2026-09-17: COMPASS Pathways reports Q2 2026 loss amid clinical progress COMPASS Pathways reported a Q2 2026 loss of $1.88 per share while advancing its synthetic psilocybin therapy, COMP360, toward a potential 2027 market launch following successful Phase III trials. 2 sources. https://clstr.news/cluster/compass-pathways-reports-q2-2026-loss-amid-clinical-progress --- Cite as: COMPASS Pathways psilocybin therapy development. CLSTR, https://clstr.news/situations/compass-pathways-psilocybin-therapy-development