Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP360, achieving the primary endpoint in treatment‑resistant depression and prompting the company to prepare a rolling NDA. Company statements and Biocentury coverage indicate COMP360 met statistical significance at six weeks in the second pivotal study and maintained effects in earlier work through 26 weeks. Compass plans regulatory meetings and intends to file a rolling submission later this year, positioning COMP360 to seek FDA approval as the first classic psychedelic therapy in the U.S. The twin Phase III readouts shift the commercial and regulatory calculus for psychedelic therapeutics and will drive discussions around labeling, administration protocols, and real‑world monitoring.