Press Release: “Compass Pathways today announced statistically significant positive results in two pivotal Phase 3 trials evaluating COMP360” | Cannabis Law Report

Press Release

Details can be found in the press release below, with key findings including:

• COMP006, which is evaluating two fixed doses of COMP360, achieved its primary endpoint; two doses of COMP360 25mg versus 1mg demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS with a mean difference of -3.8 comparing 25mg to 1mg (p<0.001).

• COMP005 maintained durability of effect at least through week 26 after just one or two doses.

• Across both trials, COMP360 was found generally safe and well-tolerated, with the vast majority of adverse events being mild to moderate and resolving on the day of treatment.

This is a remarkable achievement in psychiatry. TRD impacts approximately 4 million patients in the U.S. for whom multiple antidepressants have provided little or no response. There are limited treatment options available and tremendous need.

Please let me know if you are interested in speaking with Compass leadership and/or a trial investigator who can provide additional context about the significance of these results for patients, the science behind COMP360 and broader implications for mental health care.

Best,

Hadley Kerr

On behalf of Compass Pathways 

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Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression

February 17, 2026

• Two highly statistically significant positive Phase 3 trials confirm highly differentiated profile for COMP360, demonstrating a level of clinical effect that has historically been extremely difficult to achieve in TRD

• COMP360 is the first classic psychedelic1 to consistently achieve a highly statistically significant result and clinically meaningful effect, with a generally well-tolerated and safe profile

• In COMP006, two doses of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant and clinically meaningful reduction in symptom severity as measured by MADRS2 with a mean difference of -3.8 comparing 25 mg to 1 mg (p<0.001)3

• Clinically meaningful reduction in MADRS (≥ 25%) observed in significant number of participants in 25mg arm of both trials with 25% in COMP005 and 39% in COMP006

• Statistically significant rapid onset from the day following administration maintained at all measured timepoints through Week 6 in both clinical trials in the 25 mg arm

• In COMP005, participants who achieved a clinically meaningful reduction in MADRS at Week 6 with COMP360 25 mg maintained durability of effect at least through Week 26 after just one or two doses

• Across both Phase 3 trials to date, COMP360 is demonstrating a generally well-tolerated and safe profile with no unexpected safety findings

• Compass has requested a meeting with the FDA to discuss a rolling submission and review and expects to complete an NDA submission in Q4

• Compass management will host a webinar on February 17th at 8:00 am ET

LONDON & NEW YORK–(BUSINESS WIRE)– Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the successful achievement of the primary endpoint in the ongoing Phase 3 COMP006 trial, the second of two Phase 3 trials, which is evaluating two fixed doses of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD). The primary endpoint was the difference in change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores between the 25 mg and 1 mg groups at Week 6. Two fixed doses – administered 3 weeks apart – of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant reduction in symptom severity with a p-value of <0.001 and a clinically meaningful difference of -3.8 points in change at the primary endpoint.

Across COMP005 and COMP006 to date, COMP360 is demonstrating a generally well-tolerated and safe profile, with treatment-emergent adverse events (TEAEs) being mild or moderate in severity, and the vast majority resolving within 24 hours. The data confirms a statistically significant rapid onset from the day following administration and maintained at all measured timepoints through Week 6 in both clinical trials in the 25 mg arm. COMP005 suggests that participants who demonstrated a clinically meaningful reduction in MADRS maintained durable treatment effect at least through Week 26, after just one or two doses. Retreatment with a second dose was well-tolerated, with a consistent safety profile.

Compass has submitted a request for a meeting with the U.S. Food and Drug Administration (FDA) to discuss a rolling submission and review.

“Across three robust, well-designed and well-executed clinical trials involving more than 1,000 participants, we have now demonstrated consistent, highly statistically significant results at the primary endpoint and a clinically meaningful effect. This is a remarkable achievement for the field of psychiatry – especially in the TRD population, where proving benefit has historically been extraordinarily challenging,” said Kabir Nath, Chief Executive Officer at Compass Pathways. “These data strengthen our conviction in the highly differentiated profile for COMP360 and given the urgent need for new treatments in TRD, we are advancing our discussions with the FDA, with the goal of submitting an NDA in Q4 and securing approval.”

“TRD patients have extremely limited treatment options, and the unmet need remains profound. The promising clinical profile of COMP360 reinforces our belief in its potential to set a new standard of care for this population,” said Dr. Guy Goodwin, Chief Medical Officer at Compass Pathways. “These results redefine rapidity and durability for TRD patients with onset as early as the next day and, for those who respond, effects from just one or two doses lasted at least through 26 weeks, alongside a well-tolerated safety profile. Across the very limited TRD treatment landscape, this potential treatment truly stands out for its extremely rapid and sustained efficacy. We are incredibly grateful to the participants, investigators, and clinical trial staff for their invaluable contributions to our trials and for making this significant progress possible.”

Key Findings

Efficacy Profile

COMP005

• Primary endpoint of Part A (previously disclosed in June 2025): Single dose of COMP360 25 mg versus placebo with a mean treatment difference of -3.6 points, 95% CI [-5.7, -1.5]; p<0.001 at Week 6 4

• For participants who had a clinically meaningful reduction in MADRS (≥ 25%), a statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in the 25 mg arm

• 25% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6 with durability lasting out through 26 weeks after just one or two doses of 25 mg

• Over 40% of those who achieved a clinically meaningful reduction in MADRS but had not remitted by 6 weeks went into remission after the second dose in Part B

COMP006

• Primary endpoint of Part A: Two doses of COMP360 25 mg versus 1 mg with a mean treatment difference of -3.8 points, 95% CI [-5.8, -1.8]; p<0.001 at Week 6

• 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6

• For participants who achieved a clinically meaningful reduction in MADRS (≥ 25%), a statistically significant rapid onset from the day following administration was maintained at all measured timepoints through Week 6 in the 25 mg arm

• The 26-week data (Part B) from COMP006 is expected in early Q3 2026

Safety Profile

The Chair of the independent Data Safety Monitoring Board (DSMB) provided the following statement: “Based on the latest review of this data for the 005 and 006 TRD studies, safety findings are consistent with previous studies of COMP360 and there are no new, unexpected or concerning safety findings. Safety findings are consistent with the known profile of the study drug (a classical psychedelic) and the treatment-resistant depression patient population. From this review of the data, there is no evidence of a clinically meaningful imbalance between treatment arms in suicidality in either study.”5

COMP005

In the 25 mg arm, (Part A and B):

• Most TEAEs occurred on the days of study drug administration (66%), with the vast majority (88%) resolving within a day

• Most common TEAEs reported were headache, nausea and visual hallucination

• There were 11 treatment-emergent serious adverse events (SAEs) from 8 participants (5%) overall

COMP006

In the 25 mg arm (Part A):

• Most TEAEs occurred on the days of study drug administration (73%) with the vast majority (83%) resolving within a day

• Most common TEAEs were headache, nausea, anxiety and visual hallucination

• There were 6 treatment-emergent serious adverse events (SAEs) from 6 participants (2%) overall

Across both trials, for the data available to date, the rate for SAE suicidal ideation was less than 1%. There was only one event of SAE suicidal behavior, which occurred in the 1 mg arm in COMP006.

Live Webcast

A replay of the webcast will be accessible for 30 days following the event.

About the COMP360 Phase 3 Program

The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD).

The ongoing COMP005 trial is a randomized, double-blind, placebo-controlled study, with 258 dosed participants across the United States and is assessing the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD (COMP360 25 mg: n=171; placebo: n=87).The trial is comprised of three parts: Part A, which was blinded through 6 weeks; Part B, which has recently concluded and was blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.

The ongoing COMP006 trial, running in parallel to the COMP005 trial, is a randomized, double-blind study with 581 dosed participants across North America and Europe and is comparing the efficacy and safety of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360 (25 mg: n=296; 10 mg: n=142; 1 mg: n=143). The trial is comprised of three parts: Part A, which has recently concluded and was blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52.

About treatment resistant depression (TRD)