TLDR
- Compass Pathways (CMPS) stock surged 33.7% Tuesday after successful COMP006 Phase 3 trial results for psilocybin-based depression treatment.
- COMP360 25mg dose achieved -3.8 point MADRS improvement versus control with p<0.001 statistical power in treatment-resistant depression patients.
- 39% of participants saw clinically meaningful depression reduction by Week 6, with benefits starting day after treatment and lasting throughout study.
- Side effects were mostly limited to administration days and resolved within 24 hours, including headache, nausea, and visual hallucinations.
- FDA meeting requested for Q2 with planned New Drug Application submission targeted for Q4 2025.
Compass Pathways Plc (CMPS) posted a massive 33.7% gain Tuesday following positive Phase 3 clinical trial results. The biotech company’s COMP360 synthetic psilocybin therapy demonstrated strong efficacy in patients with treatment-resistant depression.
The COMP006 trial achieved its primary endpoint with high statistical power. Patients receiving two 25mg doses showed a -3.8 point mean improvement on the Montgomery-Åsberg Depression Rating Scale versus the 1mg control arm, reaching p<0.001 statistical measure.
This represents the second successful Phase 3 trial for COMP360. The company now has dual positive datasets supporting regulatory approval efforts.
Rapid Response and Lasting Benefits
39% of participants in the 25mg group achieved clinically meaningful depression reduction at the six-week mark. Treatment effects appeared quickly, beginning the day following administration.
Data from the earlier COMP005 trial showed response durability extending through Week 26. Patients maintained benefits after receiving only one or two treatment doses.
This rapid-acting profile contrasts sharply with conventional antidepressants that require weeks of daily use before therapeutic effects emerge.
Safety Data and Analyst Response
COMP360 showed a manageable safety profile across both Phase 3 studies. Most adverse events occurred on dosing days and resolved within 24 hours.
Common side effects included headache, nausea, and visual hallucinations. The trials revealed no concerning suicidality signals, addressing a critical safety consideration for depression therapies.
TD Cowen analyst Ritu Baral maintained a Buy rating with a $29 price target. Baral highlighted the robust efficacy signals and clean safety profile as key rating drivers.
The analyst noted that many initial responders achieved remission after a second dose. This supports the commercial potential of a repeat-dosing treatment strategy.
LifeSci Capital also maintained its Buy rating with a $19 price target on CMPS stock.
Path to FDA Submission
CEO Kabir Nath stated the results strengthen conviction in COMP360’s differentiated profile. He emphasized the urgent need for new treatment-resistant depression options.
Compass has requested a pre-NDA meeting with the FDA in early Q2. The company will discuss rolling submission and review procedures.
Management targets New Drug Application completion in Q4 2025. This filing would mark a major regulatory milestone toward potential approval.
Treatment-resistant depression affects millions who don’t respond to standard medications. The condition represents a large commercial opportunity for effective new therapies.
COMP360’s approach requires just one or two sessions instead of daily medication. The 25mg dose showed consistent results across both pivotal trials, strengthening the regulatory case.
Compass Pathways plans to complete its NDA submission in the fourth quarter after meeting with FDA regulators to finalize the rolling submission process.
