All articles tagged with #compass pathways
Compass Pathways reported two positive late-stage trials of a synthetic psilocybin treatment that rapidly reduces symptoms in patients with treatment-resistant depression, potentially becoming the first psychedelic medicine to gain full regulatory approval if the FDA approves it early next year.
Compass Pathways reports positive Phase 3 results for its psilocybin-based treatment COMP360 in two trials for severe depression, suggesting potential FDA approval, though full data are needed to confirm the magnitude of benefit; if approved, it could become the first psilocybin product on the market, following Spravato (ketamine derivative).
Compass Pathways announced positive results from the largest-ever Phase 3 study of psilocybin for treatment-resistant depression, showing a significant reduction in depression scores, though investor response was muted due to the effect size not being larger. The study met its primary endpoint, and safety data was favorable, marking a key step toward potential approval.
Compass Pathways' Phase 3 trial of its synthetic psilocybin, COMP360, showed a significant separation from placebo in treating treatment-resistant depression, with no new safety concerns, marking a major milestone for psychedelic drug development. The company is now focusing on a larger, multi-dose trial expected to provide clearer efficacy data and aims for FDA submission, while preparing for potential U.S. market launch.
Compass Pathways announced positive results from its Phase 3 trial of COMP360, a synthetic psilocybin formulation, showing significant reduction in depression symptoms in treatment-resistant depression patients, with safety findings consistent with previous studies. The company plans to discuss these results with the FDA and continues its research with further trials.