Compass Pathways reported a second positive Phase III readout for its synthetic psilocybin candidate COMP360 in treatment-resistant depression, reinforcing efficacy signals from an earlier pivotal trial and prompting the company to plan a rolling NDA submission. The firm said the combined pivotal dataset supports plans to meet with the FDA and pursue approval next year. COMP360 achieved statistically significant reductions in standard depression scales in the second trial, and Compass described the therapy as well tolerated. The company will pursue regulatory discussions to align on submission content and a pathway to market, seeking to become the first developer to obtain approval for a classic psychedelic therapy in the U.S. For biopharma stakeholders, the development accelerates commercial and regulatory interest in psychedelic medicine and is likely to drive additional funding, partnerships, and competitive positioning across psychiatric drug development.