Compass Pathways disclosed positive results from a second Phase III study of its synthetic psilocybin candidate COMP360 in treatment‑resistant depression, reporting statistically significant reductions in depression scores and tolerability consistent with earlier data. The company said it will meet with the FDA and is preparing a rolling NDA submission, targeting a filing window between October and December. Investors reacted strongly: shares rallied across psychedelics developers as the readouts strengthen the case for a first‑in‑class classic psychedelic approval. Compass framed the results as confirmatory evidence to support regulatory discussions and potential labeling strategies. The readouts could reshape commercial and clinical positioning in psychiatric drug development if regulators accept the totality of evidence.