Compass Pathways touts Phase 3 COMP360 depression results, a rolling NDA plan, and 2026 launch readiness (April 15, 2026)

COMP360 Phase 3 results are reported for Compass Pathways as showing rapid, durable antidepressant effects in treatment-resistant depression, with the 25 mg dose producing a statistically significant and clinically meaningful improvement on MADRS versus placebo or 1 mg. Company executives say onset is seen by early day two and benefit lasts out to at least 26 weeks, while safety appears manageable with mostly transient dosing-day adverse effects and no DSMB signals of concerning suicidality imbalances. Regulatory and launch plans center on a potential rolling NDA aligned with regulators, with submission timing tied to adding 26-week data from a second study and targeting readiness for a year-end commercial launch. Commercialization strategy focuses on leveraging the existing SPRAVATO clinic infrastructure for supervised, multi-hour treatment delivery, plus reimbursement via new CPT codes, training grants, and attention to near-term controlled-substance rescheduling at DEA and the state level.