Compass Pathways reported a second positive Phase III readout for its synthetic psilocybin candidate COMP360 in treatment‑resistant depression, repeating efficacy seen in an earlier pivotal trial. The company said the new data bolster a planned rolling NDA submission and that it will meet with the FDA to discuss next steps toward approval. Compass described the asset as well tolerated across trials; the results have lifted investor interest in the psychedelics sector and could position COMP360 as the first classic psychedelic to seek U.S. registration. Clinicians and regulators will evaluate durability, safety and trial subgroup signals as Compass advances its regulatory package.
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