Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP360, and is preparing to push a rolling NDA toward U.S. regulators. The company disclosed two pivotal trials meeting primary endpoints, with the second study reinforcing the six-week antidepressant signal and durability seen in the earlier trial. Compass plans a rolling submission later this year aimed at potential approval within the next 12 months. The data come from the firm’s COMP005/COMP006 pivotal program and were released in company statements and clinical summaries. Investigators measured standard depression scales (including the Montgomery–Åsberg Depression Rating Scale) at week six and maintained effects through later timepoints in the earlier trial. Compass has breakthrough therapy designation for COMP360 and intends to coordinate next steps with the FDA. Investors reacted strongly to the readouts, sending Compass shares higher and prompting company guidance toward regulatory meetings and an accelerated filing timeline. Clinical details remain limited pending full datasets; the company indicated it will provide more granular results ahead of regulatory interactions.