Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, today announced its participation at Psych Congress 2026, taking place in New Orleans, LA, from September 14-19. The Company will debut Change the Tune in TRD, a new educational campaign for U.S. HCPs focused on TRD, and present new HEOR data examining the burden of TRD alongside encore presentations from its COMP360 psilocybin clinical development program.
Change the Tune in TRD: Advancing HCP Education
Change the Tune in TRD is a new educational initiative for U.S. HCPs exploring the neurobiology and navigating care pathways in TRD. The campaign will be debuted in a three-panel Innovation Theater on September 15th from 12:15-1:30pm in Room 220-222. The featured panelists include:
- Saundra Jain MA, PsyD, LPC, Psychotherapist, Adjunct Clinical Affiliate, University of Texas at Austin School of Nursing; Private Practice, Austin, Texas
- Bryan B. Shapiro MD MPH, Board-Certified Psychiatrist, Assistant Clinical Professor of Psychiatry, UC Irvine Medical Center
- Sandhya Prashad, MD, Interventional Psychiatrist, Founder and medical director of Sandhya J. Prashad, MD, Houston Ketamine Therapeutics, and Houston TMS Therapeutics
New HEOR Data
- Real-World Healthcare Costs and Resource Utilization Across Health States Among Patients with Treatment-Resistant Depression – presented by Yechu Hua, poster #186
- Characterization of Depression Episodes to Inform Real-World Health States for Major Depressive Disorder and Treatment-Resistant Depression – presented by Vicki Wing, poster #88
- Behavioral Health Provider Perspectives on Management of Individuals with TRD – presented by Caroline Hostetler, poster #95
- Identifying Treatment-Resistant Depression in the Real-World: Clinical Practice and Barriers to Care – presented by Matthew Sidovar, poster #89
Encore COMP360 Presentations
- Demographic and Clinical Characteristics of Participants Receiving COMP360 Psilocybin Treatment for Treatment-Resistant Depression Across Two Pivotal Phase 3 Trials – presented by Kevin Loh, poster #93
- Durability of Efficacy and Safety of COMP360 Psilocybin for Treatment-resistant Depression Across 26 Weeks in a Double-blind, Randomised, Controlled Phase 3 Study – presented by Collin Challis, poster #92
- Efficacy and Safety of COMP360 Psilocybin for Treatment-resistant Depression (TRD) in Two Phase 3, Double-blind, Randomized, Controlled Studies – presented by Juliana Gassmann, poster #91
Additional Congress Activities
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Disease State Booth: #901
Medical Booth: #937
About treatment resistant depression (TRD)
Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030.
It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD1. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD.
About Compass Pathways
We believe mental health patients deserve the possibility of a better future. Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world’s largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing.
Compass is headquartered in London, UK, with a U.S. office in New York.
We are driven by our purpose of unlocking pathways to be – opening futures filled with possibility. Together, we are on an ambitious journey toward enabling people living with mental health conditions to find clarity through self-discovery, because every journey needs a Compass.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD; any implication that preliminary results will be predictive of full safety and efficacy data from our phase 3 program; the potential for our current or any future clinical trials to support regulatory filings and approvals for COMP360 psilocybin treatment on an accelerated basis or at all; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; our expectations regarding our commercial readiness, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof.
1. Wing V, et al. Poster S97 Contemporary Estimate of the National Prevalence of Treatment-Resistant Depression in the United States. Presented at ADAA 2026.
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