Zinger Key Points
- COMP360 shows a significant reduction in depression symptoms six weeks after a single dose, meeting the trial’s primary goal.
- "We eagerly anticipate further insights once we have the full dataset," the company says.
- Get access to the leaderboards pointing to tomorrow’s biggest stock movers.
COMPASS Pathways Plc CMPS stock is trading lower on Monday. The company announced it reached its primary endpoint in the ongoing Phase 3 COMP005 trial, but results may have not met lofty investor expectations.
What To Know: The study evaluated COMP360, a single-dose treatment consisting of a synthetic, proprietary formulation of psilocybin, for people with treatment-resistant depression.
A single dose of COMP360 demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity compared to placebo based on the Montgomery-Åsberg Depression Rating Scale (MADRS).
The primary goal was to measure changes in depression severity six weeks after treatment. Compass said the ongoing Phase 3 trial met its primary endpoint. The company reported a clinically meaningful difference of -3.6 in change at the primary endpoint, which may be impacting the stock Monday afternoon.
An independent safety board reviewed the data and reported no unexpected safety issues or meaningful differences in suicidal ideation between groups. The company also plans to discuss the preliminary results with the U.S. Food and Drug Administration (FDA), which has not yet reviewed the data.
The company said a second Phase 3 trial remains underway, with 26-week results expected in the second half of 2026.
“We eagerly anticipate further insights once we have the full dataset, and also look forward to findings from COMP006, which will explore the efficacy of two fixed doses,” said Kabir Nath, CEO of Compass Pathways.
Evercore ISI Group analyst Josh Schimmer downgraded Compass Pathways from Outperform to In-Line and lowered the price target from $11 to $6, which appears to be adding to the sell-off on Monday.
CMPS Price Action: At the time of publication, Compass shares were down 46.2% at $2.49, according to data from Benzinga Pro.
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