'360 Two-Dose '006 Data: Dose-Dependent, Durable Benefit, Solid LT Remissions

研报英文原文证据摘录

'360 Two-Dose '006 Data: Dose-Dependent, Durable Benefit, Solid LT Remissions

TD Cowen COMPASS Pathways

Global Research July 7, 2026

window and provides support for a flexible redosing approach in patients who have not yet

remitted.

Further, durability out to 6 mo. suggests many patients may require only 3–4 treatments per

year, representing a substantially lower treatment burden than Spravato, which requires

ongoing weekly or every-other-week maintenance dosing to sustain treatment effect.

We also note that enrolled patients had baseline MADRS scores of ~32, consistent with

severe depression, placing them among the more difficult-to-treat patients. Our KOLs have

consistently emphasized that remission in this population is very challenging, underscoring the

clinical meaningfulness of '360's rapidity of effect, meaningful remission rates, and durable

clinical benefit.

On safety, our KOLs have emphasized that suicidality is inherent to TRD disease pathology

and view suicidal ideation, attempts, or completed suicide as expected, provided there is

no meaningful imbalance between treatment arms. One KOL indicated previously that 1–2

suicides are unavoidable in large TRD clinical trials.

In study '006, these events appeared balanced, with one completed suicide in the 25mg arm

and one case of suicidal behavior/suicide attempt in the 1mg arm. Importantly, the patient

who died by suicide did so ~80 days after treatment, and the investigator deemed the event

unrelated to '360. While any such event is unfortunate, we do not believe the available data

suggests a treatment-related safety signal. For context, the Spravato development program

reported 3 completed suicides across a safety database of >1,700 patients, highlighting the