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LONDON - Compass Pathways plc (NASDAQ:CMPS), a $433 million market cap biotech company currently rated as undervalued according to InvestingPro analysis, announced Monday that its investigational psilocybin treatment COMP360 met the primary endpoint in its Phase 3 COMP005 trial for treatment-resistant depression (TRD). The company maintains a strong financial position, with cash reserves exceeding debt obligations.
The study showed a single 25 mg dose of COMP360 demonstrated a statistically significant reduction in depression symptom severity compared to placebo, with a mean difference of -3.6 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6 (p
The COMP005 trial represents the first Phase 3 efficacy data reported for an investigational synthetic psilocybin treatment and the first for a classic psychedelic. The randomized, double-blind, placebo-controlled study dosed 258 participants across 32 U.S. sites.
An independent Data Safety Monitoring Board reviewing safety data found no unexpected safety issues and no clinically meaningful imbalance in suicidal ideation between treatment and placebo groups.
"Based on the latest review of the data for the 005 and 006 studies, safety findings are consistent with previous studies of COMP360 and there are no new or unexpected safety findings," stated the DSMB chair in the press release.
Compass Pathways is conducting a second pivotal Phase 3 trial, COMP006, which continues to enroll participants. This parallel study aims to compare two fixed doses of COMP360 (25 mg and 10 mg) to a 1 mg dose, with 26-week data expected in the second half of 2026.
The company plans to discuss the preliminary COMP005 data with the U.S. Food and Drug Administration, which has not yet reviewed the results. With a healthy current ratio of 10.18 and minimal debt-to-equity of 0.16, Compass appears well-positioned to continue its clinical development program. Discover more detailed financial metrics and 6 additional key ProTips with InvestingPro’s comprehensive research reports.
Treatment-resistant depression affects approximately one-third of the estimated 21 million U.S. adults with major depressive disorder, according to information provided in the company statement. The stock has shown strong momentum with a 22.49% year-to-date return, reflecting growing investor confidence in the company’s potential to address this significant market opportunity.
The company expects to share 26-week data for COMP005 after all participants in the COMP006 trial complete part A of that study.
In other recent news, Compass Pathways has reported several significant developments. The company held its 2025 Annual General Meeting, where all proposed resolutions were passed, including the re-election of directors and the appointment of PricewaterhouseCoopers LLP as the UK statutory auditor. In a notable change, Compass Pathways has appointed PricewaterhouseCoopers LLP in the United States as its new independent registered public accounting firm for the fiscal year ending December 31, 2025. This transition aligns with the company’s growing presence in the United States. Additionally, the Compensation and Leadership Development Committee approved amendments to executive employment agreements, allowing for accelerated vesting of equity awards under specific conditions.
On the analyst front, TD Cowen reiterated its Buy rating on Compass Pathways, maintaining a price target of $23.00. The firm expressed confidence in the company’s potential, particularly concerning the upcoming Phase 3 trial results for its ’360 product. Similarly, Stifel analysts maintained their Buy rating with an $11.00 price target, emphasizing the significance of the ’005 study and Compass’s commercial strategy. The analysts noted the company’s preparedness for regulatory approval and commercialization, drawing parallels to the market success of Spravato. These developments indicate a period of strategic adjustments and analyst optimism for Compass Pathways.
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