Compass Pathways reported positive results from a second Phase III trial of its synthetic psilocybin therapy COMP360 for treatment‑resistant depression, with the high-dose arm showing statistically meaningful symptom reductions and acceptable tolerability. The company said it will meet the FDA to discuss a rolling submission and aims to file an approval application between October and December. Market response lifted psych‑drug equities across the sector. Investors and analysts flagged that repeated positive late‑stage data strengthens regulatory discussions and could create the first classical psychedelic approval pathway if regulators concur on benefit–risk.
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