Compass Pathways reported a second successful Phase 3 study for its COMP360 psilocybin formulation in treatment‑resistant depression, prompting management to pursue regulatory filings. The company disclosed positive pivotal outcomes across two trials and signaled plans to engage regulators on a path to approval. Investors reacted strongly to the topline results, lifting the stock and sparking discussion about COMP360 becoming the first regulated psilocybin product in major markets. Independent experts noted the effect sizes likely meet approval thresholds but emphasized that detailed safety and durability data will determine commercial prospects. Compass now faces standard next steps: full data releases, agency interactions, and potential submission timing. The trials position the company to lead a nascent psychedelics approval wave should regulators accept the totality of evidence.