TLDR
- Compass Pathways (CMPS) stock jumped 33.7% Tuesday after its COMP006 Phase 3 trial met primary endpoints for COMP360 psilocybin therapy in treatment-resistant depression.
- The 25mg dose showed a -3.8 point improvement on depression scales versus control group with high statistical power (p<0.001).
- 39% of participants achieved clinically meaningful depression reduction at Week 6, with effects starting the day after treatment and lasting through the measurement period.
- Most side effects occurred on administration days and resolved within 24 hours, with headache, nausea, and visual hallucination being most common.
- Company plans to complete New Drug Application submission in Q4 2025 after meeting with FDA to discuss rolling submission process.
Compass Pathways Plc (CMPS) delivered a 33.7% gain Tuesday after announcing positive results from its second Phase 3 clinical trial. The company’s COMP360 synthetic psilocybin therapy showed strong efficacy in treating treatment-resistant depression.
The COMP006 trial met its primary endpoint with high statistical power. Participants receiving two 25mg doses of COMP360 showed a mean improvement of -3.8 points on the Montgomery-Åsberg Depression Rating Scale compared to the 1mg control group. The result achieved p<0.001 statistical measure.
This marks the second successful Phase 3 trial for the psilocybin-based treatment. The company now has two positive datasets supporting potential FDA approval.
Treatment Response and Duration
39% of participants in the 25mg treatment group achieved clinically meaningful depression reduction by Week 6. The therapeutic effect appeared rapidly, beginning the day after administration.
Previous trial data from COMP005 showed durability of response. Participants who responded to treatment maintained benefits through at least Week 26 after receiving just one or two doses.
The rapid onset differentiates COMP360 from traditional antidepressants. Standard medications typically require weeks of daily dosing before showing effects.
Safety Profile and Side Effects
The treatment demonstrated a manageable safety profile across both Phase 3 trials. Most adverse events occurred on the days participants received doses.
The majority of side effects resolved within 24 hours. The most frequently reported issues were headache, nausea, and visual hallucination.
The company reported no concerning suicidality signals in the trial data. This addresses a key safety consideration for depression treatments.
TD Cowen analyst Ritu Baral maintained a Buy rating with a $29 price target following the results. The analyst highlighted the clean safety profile and strong efficacy signals as key factors.
Baral noted that a large subgroup showed high responsiveness to treatment. Many initial responders converted to remission after receiving a second dose, supporting the commercial potential of repeat dosing.
LifeSci Capital also reiterated its Buy rating with a $19 price target. Both analyst firms view the regulatory pathway favorably.
Compass Pathways CEO Kabir Nath said the data strengthens conviction in COMP360’s profile. He emphasized the urgent need for new treatment-resistant depression therapies.
The company has requested a pre-NDA meeting with the FDA scheduled for early Q2. Management plans to discuss a rolling submission and review process.
Compass intends to complete its New Drug Application submission in the fourth quarter of 2025. The filing would represent a major milestone toward potential FDA approval.
The successful COMP006 trial adds to growing evidence for psychedelic-based mental health treatments. COMP360 requires only one or two treatment sessions rather than daily medication.
Treatment-resistant depression affects millions of patients who fail to respond to standard antidepressants. The market represents a major commercial opportunity for effective new therapies.
The 25mg dose showed consistent results across both Phase 3 trials. This reproducibility strengthens the regulatory case for approval.
Compass Pathways has now met with the FDA to discuss the rolling NDA submission process for Q4 2025.
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