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Compass Pathways

All articles tagged with #compass pathways

politics1 month ago•2 min saved

Trump pushes fast-track reviews for psychedelic medicines

President Trump issued an executive order directing the FDA (and DEA) to fast-track reviews for psychedelic drugs and to establish a pathway for access to investigational psychedelics under FDA review, including granting priority review vouchers for three serotonin 2A agonists. Companies like Compass Pathways welcomed the move as a step toward faster, regulated access to psychedelic medicines for mental illness while maintaining scientific rigor.

via Fierce Biotech|

#breakthrough-therapy-designation #compass-pathways #executive-order

health3 months ago•6 min saved

Psilocybin-based therapy shows rapid relief in treatment-resistant depression, eyeing FDA approval

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.

via The Economist|

#compass-pathways #depression #fda

biotech3 months ago•2 min saved

Compass’s psilocybin therapy advances toward FDA nod in severe depression

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).

via statnews.com|

#biotech #comp360 #compass-pathways

health11 months ago•1 min saved

Compass Psilocybin Therapy Achieves Key Phase 3 Success in Depression Treatment

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.

via STAT|

#clinical-trial #compass-pathways #depression

business11 months ago•11 min saved

Compass Psilocybin Achieves Key Phase 3 Success in Depression Treatment

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.

via Psychedelic Alpha|

#business #compass-pathways #phase-3-trial

health11 months ago•8 min saved

Compass Pathways' Psilocybin Achieves Phase 3 Success for Treatment-Resistant Depression

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.

via Business Wire|

#clinical-trial #compass-pathways #depression