Compass Pathways reported a second positive Phase III trial for its synthetic psilocybin candidate COMP‑360 in treatment‑resistant depression, enabling the company to prepare a rolling NDA and pursue U.S. approval. The two successful pivotal trials showed statistically significant improvements versus control on depression scales at six weeks and maintained effects through later time points in at least one study. Compass said it will complete a rolling submission by year‑end and seek regulatory meetings; industry analysts note the data may meet approval thresholds but that detailed safety and remission figures will determine commercial and clinical uptake. The outcome would position COMP‑360 as the first classic psychedelic therapy to secure regulatory clearance in the U.S.