COMPASS Pathways (NASDAQ:CMPS) provided updates on its COMP360 psilocybin programs in post-traumatic stress disorder (PTSD) and treatment-resistant depression (TRD) during a company webinar, outlining a newly designed pivotal PTSD trial, progress in ongoing phase 3 TRD studies, and commercial preparation steps aimed at a potential launch.
PTSD program: pivotal phase 2b/3 trial design
Chief Executive Officer Kabir Nath said the company announced the design of a pivotal phase 2b/3 trial in PTSD, calling the condition a larger patient population than TRD and citing an estimate of 13 million people affected in the U.S. Nath said there have been no new medicines approved for PTSD in decades.
Chief R&D Officer Mike Gold reviewed COMPASS’ earlier open-label phase 2 PTSD study in 22 patients across U.S. and U.K. sites. Gold said the study tested a single 25 mg dose of COMP360 and showed a large benefit on the CAPS-5 PTSD rating scale sustained through week 12, with no serious adverse events observed.
Gold said the new PTSD trial is a three-arm phase 2b/3 study evaluating two administrations of 25 mg COMP360 compared with a 1 mg active control, with dosing four weeks apart. He said the primary endpoint will be CAPS-5 at week 8, with PCL-5 as a key secondary endpoint. Part A is a 12-week, randomized, controlled, double-blind portion, followed by Part B, a 40-week open-label period for a total of 52 weeks. Gold added that non-responders, and responders who later relapse, may have an opportunity for another dose in Part B. He said the company has selected a CRO, is selecting sites and investigators, expects to start screening patients this quarter, and noted the company’s IND has been accepted by the FDA.
In Q&A, Gold said the study is not powered on a specific PCL-5 effect and emphasized that CAPS-5 must be met first in the study’s statistical framework. He also said inclusion and exclusion criteria were discussed with the FDA, which had “virtually no comments,” and that the company aimed for a more real-world population by allowing some degree of alcohol and substance use given common comorbidities.
TRD program: phase 3 progress and upcoming data
Nath said COMPASS has “made excellent progress” in TRD, including completing enrollment ahead of schedule in its COMP006 phase 3 trial. He also said the company has seen “openness by the FDA to a rolling submission and review,” which he said contributed to accelerated launch timelines.
Gold and guest speaker Dr. Gary Small, Director of Behavioral Health Breakthrough Therapies at Hackensack Meridian Health, discussed TRD’s treatment landscape. Small described TRD as generally defined by inadequate response to two or more antidepressants despite adequate treatment and adherence. He said TRD accounts for about a third of major depression patients and cited a company estimate of about four million TRD patients in the U.S., with an estimated 100 million worldwide. Small said current strategies often involve extending antidepressant trials, switching or combining medications, psychotherapy, or neuromodulation such as ECT or TMS, each with limitations related to time to response, tolerability, or accessibility.
How COMP360 may differ from Spravato and what delivery could look like
Chief Patient Officer Dr. Steve Levine compared COMP360’s emerging profile with intranasal esketamine (Spravato), which he described as the only TRD medicine commonly prescribed in practice. Levine said Spravato requires repeated, time-intensive appointments—twice weekly in the first month, weekly in weeks five through eight, and then weekly or biweekly maintenance—adding up to 25–35 treatments per year or more. He emphasized the burden on patients and caregivers, including an inability to drive after treatment and frequent time away from work.
Levine also focused on provider economics, saying there are no dedicated CPT codes that adequately reimburse for Spravato monitoring and clinical time. He said COMPASS helped design new CPT codes specific to psychedelic administration that are reimbursable on an hourly basis and are already approved, enabling reimbursement for a full six-to-eight-hour session if needed.
Levine said phase 2b data and top-line results from the COMP005 phase 3 study show “immediate robust response” and durability after a single dose, and he said COMP005 showed an effect size at week 6 comparable to Spravato’s effect size at week 6, which he noted requires 10 Spravato administrations over that time. He said most adverse events in phase 2b were mild to moderate and generally resolved the day after administration, with 100% adherence due to single-dose treatment.
Commercial readiness: centers, payer work, and access plans
Chief Commercial Officer Lori Engelbert said the company is working to be “launch-ready by the end of the year.” She said pre-commercial efforts have focused on stakeholder engagement across clinical teams, strategic collaborations, policymakers, and patient advocacy groups, and she noted the company has begun preliminary discussions with payers but plans more robust engagement after additional phase 3 data.
Engelbert said COMP360 is expected to fit within existing interventional psychiatry infrastructure, citing more than 6,800 centers currently delivering Spravato. She said prescribing would be by a licensed prescriber, with monitoring on the dosing day by a trained licensed healthcare professional; in trials, monitoring and support were provided by a licensed therapist. She said the company expects to make COMP360 available through both specialty pharmacy (shipped to the site of care) and buy-and-bill, with drug reimbursement billed to pharmacy benefit and session monitoring billed via medical benefit using the new CPT codes.
Engelbert also previewed upcoming data releases: COMP006 Part A efficacy data at the primary endpoint of six weeks in Q1, as well as COMP005 Part B data out to 26 weeks in Q1. She said the 26-week data will include MADRS curves for remitters, responders, partial responders, and non-responders, which she said could help inform clinical decision-making and early payer discussions around dosing frequency.
Strategic collaboration partners discuss demand and scaling
Levine hosted a discussion with representatives from Greenbrook (a Neuronetics subsidiary), Journey Clinical, and Healthport (a certified community behavioral health clinic, or CCBHC). Dr. Jeffrey Grammer, Greenbrook’s Chief Medical Officer, said the organization operates 95 centers and performs about 800 TMS treatments and 400 Spravato treatments on a given day. Grammer described strong patient interest in psilocybin, including from patients in remission on existing treatments, and said Greenbrook is modifying workflows and rooms in preparation for potential COMP360 delivery.
Miriam Barth, co-founder and CEO of Journey Clinical, said the company partners with more than 3,000 therapists through a collaborative care model and has delivered about 500,000 hours of treatment, including ketamine-assisted psychotherapy and Spravato. She said Journey Clinical would adapt existing protocols to COMP360, with dosing sessions monitored in therapy practices and psychotherapy provided pre- and post-treatment, while noting there is no active therapy during dosing sessions.
Dimitri Kavathis, CEO of Healthport, emphasized equitable access and said more than 500 CCBHCs across 46 states, Washington, D.C., Puerto Rico, and Guam serve more than three million people. He said CCBHCs could help ensure access does not skew toward only well-insured or high-net-worth patients, and he highlighted the role of clinics in underserved areas.
Nath said the company recently announced its seventh strategic collaboration, with Radial Health, and described 2026 as positioned to be a “landmark year” for TRD patients and the company. He said COMPASS expects to report pivotal data from COMP006 later this quarter and continues to prepare NDA submission activities while expanding commercial readiness efforts.
About COMPASS Pathways (NASDAQ:CMPS)
COMPASS Pathways (NASDAQ: CMPS) is a clinical-stage biotechnology company focused on the development and commercialization of psilocybin therapy for mental health disorders. Founded in 2016 and headquartered in London with additional offices in the United States, COMPASS Pathways is pioneering the use of synthetic psilocybin combined with psychotherapy to address treatment-resistant depression. The company’s flagship program is a Phase IIb clinical trial evaluating COMP360, its proprietary psilocybin formulation, which has received Breakthrough Therapy designation from the U.S.
