Compass Pathways reported a second positive Phase III trial for COMP360, its synthetic psilocybin therapy for treatment‑resistant depression, and said it will move toward a rolling NDA submission. The company plans to meet with the FDA to discuss a filing timeline and aims to submit in late 2026, positioning COMP360 to be the first classic psychedelic therapy seeking U.S. approval. The second pivotal study replicated efficacy and tolerability signals observed in the earlier trial; Compass highlighted statistically significant reductions on depression rating scales at primary endpoints. The results prompted a sharp re‑rating across psychedelic biotech stocks and reignited commercial conversations about therapy delivery, reimbursement and clinic rollout. Compass executives said the dataset supports regulatory engagement and commercialization planning. Competitors and investors are now recalibrating timelines for other late‑stage psychedelic programs as the field pivots from exploratory research to potential market entry.