Compass Pathways reported positive results from two Phase 3 trials of its psilocybin therapy COMP360, and the company is preparing regulatory discussions aimed at seeking approval. The firm disclosed greater improvements in depression scores versus control arms across both studies, prompting a rapid market reaction and a notable share-price jump. Experts cited by STAT described the results as meeting the likely threshold for approval but urged caution: they noted effect sizes were not transformative and that full data disclosure is needed to assess clinical benefit and safety in diverse populations. Compass plans to aggregate datasets and engage regulators to determine next steps for a potential New Drug Application (NDA). For investors and competitors, the takeaway is pragmatic: a second pivotal win materially accelerates a commercialization timeline for a novel psychedelic modality, but endpoints, durability of response, and implementation—clinic-based dosing and psychotherapy—remain open questions. Regulators will want granular efficacy and safety data before awarding a market authorization.