Compass Pathways Discloses New Results for Its Synthetic Psilocybin Patent for Treatment-Resistant Depression; Promises Commercialisation by Year-End

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Compass Pathways, the British psychedelic technology innovation company, announced this past February 17, 2026, the new results from its second Phase 3 research trial. The study evaluated the use of COMP360 (the company’s patented synthetic version of psilocybin) for the treatment of resistant depression. The two Phase 3 trials (COMP005 and COMP006) utilised COMP360 in a total of over 800 patients. The company claims it is ready to commercialize the substance by the end of the year, provided they receive FDA approval.

Although the research has not yet been published in a scientific journal or peer-reviewed, the company announced that participants who received two 25mg doses of COMP360 showed a clinically and statistically significant reduction in depressive symptoms compared to the control group (which received 1mg doses): a mean difference of -3.8 points on the MADRS scale (p<0.001), with rapid onset of action and sustained effects up to the 6th week following administration. The company's shares have surged by 30% since the announcement.

The results presented now are similar to those of the previous study (COMP005), released by the company in June 2025, where the score difference between the control group and the group receiving a single 25mg dose was -3.6 points.

Despite this, in a post on X (formerly Twitter), UCSF researcher Balázs Szigeti noted that Compass changed its definition of "clinically significant" in the current results compared to previous ones. While the company’s earlier research used a 50% reduction as the criterion for this definition, the current trial (COMP006) categorized results with a reduction of over 25% as significant. Robin Carhart-Harris also pointed out this same inconsistency on social media, although he considers that a 25% decrease could indeed be deemed "clinically significant."

The portal Psychedelic Alpha spoke with expert researchers, including Robin Carhart-Harris, who believe that FDA approval of COMP360 is now merely a matter of time. According to Sandeep Nayak, director of the Johns Hopkins Center for Psychedelic and Consciousness Research, certain characteristics of the study favor a positive decision. These findings address some of the gaps highlighted by the FDA during Lykos Therapeutics' MDMA regulation proposal, such as: he small proportion of participants with prior psychedelic experience, and the rigorous recording of adverse events related to the use of the substance.