Two positive Phase 3 trials and a priority voucher put COMP360 at the FDA door — approval plus DEA rescheduling must both clear for a commercial launch

COMPASS Pathways is a clinical-stage company developing psilocybin therapy for treatment-resistant depression, a condition not yet approved for this type of treatment.

COMP360 (psilocybin therapy) backed by two Phase 3 wins in treatment-resistant depression across more than 1,000 patients, with durable benefit through 26 weeks, is now under rolling FDA review accelerated by a National Priority Voucher. The thesis resolves on whether FDA grants approval and DEA completes rescheduling, since both are required before a commercial launch can occur. The novel modality, a single-administration psychedelic requiring supervised clinical settings, creates an untested reimbursement and site-of-care infrastructure risk that conventional antidepressant approvals have never faced.