Compass Pathways (NASDAQ:CMPS)'s COMP360 treatment model may face fewer regulatory hurdles as new Phase II analysis distinguishes the company’s psychological support approach from psychotherapy, Jefferies analysts have highlighted.
In a note reviewing a post-hoc analysis of Compass Pathways (NASDAQ:CMPS)’ completed Phase II open-label trial of COMP360 in post-traumatic stress disorder (PTSD), Jefferies wrote that the study provided further detail on how the company’s treatment model separates monitoring and support during dosing sessions from traditional talk therapy.
The analysis examined audio recordings from 22 participants during COMP360 administration sessions, measuring interactions between patients and support providers. Jefferies highlighted that 78% of the more than six-hour dosing sessions were spent in silence, with providers largely remaining outside patients’ awareness while remaining available if needed.
The analysts wrote that the findings suggest the psychedelic experience was primarily inward-focused, with support staff serving a safety-monitoring role rather than actively engaging in psychotherapy. During the post-treatment integration period, participants spoke significantly more than providers, indicating that the sessions allowed patients to reflect on their experiences.
Although the analysis was conducted in a PTSD trial rather than Compass Pathways’ treatment-resistant depression (TRD) program, Jefferies noted that the company has applied a similar psychological support model across its clinical programs.
The report comes ahead of a September 2026 FDA hearing on psychedelics and Compass Pathways’ potential regulatory review of COMP360 for TRD. Jefferies estimated it has 75% to 85% confidence that the FDA will approve COMP360 for TRD by the end of 2026, citing positive results from three Phase IIb/III datasets, the therapy’s FDA Breakthrough Therapy Designation and the company’s receipt of an FDA CNPV voucher.
Jefferies also pointed to broader industry developments supporting the potential adoption of psychedelic treatments, including increasing interest from pharmaceutical companies and growing infrastructure for supervised psychedelic therapies. The analysts highlighted Spravato’s commercial performance as an indicator that patient demand and treatment-center capacity may support future adoption of COMP360.
The analysts wrote that the FDA’s recent psychedelic guidance further supports the distinction between psychological support and psychotherapy, noting that regulators have focused on evaluating whether psychotherapy contributes to treatment effects while psychological support is intended primarily to maintain patient safety.
Jefferies also noted that Compass Pathways’ trial design differs from the approach taken by Lykos Therapeutics’ MDMA-assisted therapy application, which was rejected by the FDA in 2024 for PTSD. The analysts wrote that the FDA had raised concerns around Lykos’ use of psychotherapy alongside treatment, among other issues.
The analysts maintained that Compass Pathways could eventually achieve peak sales of more than $1.5 billion, which they estimated could support a valuation of $3 billion to $4.5 billion based on a 2-3x multiple.
Shares of Compass Pathways are up about 80% so far this year, trading hands at about $12.