Compass Pathways (NASDAQ:CMPS) said it remains on track to complete its rolling New Drug Application submission for COMP360 in the fourth quarter of 2026, following positive Phase III studies of its synthetic psilocybin treatment in treatment-resistant depression, or TRD.
During H.C. Wainwright’s Global Investor Conference, Chief Executive Officer Kabir Nath said the company has submitted all NDA modules except the clinical module, which is being finalized following the completion of integrated summaries from two Phase III trials involving nearly 900 patients.
Phase III Results and Durability
Nath said COMP005 evaluated a single 25-milligram dose of COMP360 against placebo, while COMP006 tested two fixed doses administered three weeks apart and compared them with 10-milligram and 1-milligram doses. At the six-week primary endpoint, both trials showed statistically significant separation from baseline on the Montgomery-Åsberg Depression Rating Scale, or MADRS, of just under four points, according to the company.
The company reported signs of improvement as early as the day after dosing. Nath said approximately one-quarter of patients receiving a single dose in COMP005 achieved a clinically meaningful response, while 40% of patients in COMP006 achieved such a response after two fixed doses.
The studies remained blinded through 26 weeks. Chief Commercial Officer Lori Englebert said the company also released open-label data through 12 months, in which eligible patients received an additional dose at 26 weeks. Compass said patients receiving that dose were able to sustain durability through the end of the year.
Englebert contrasted COMP360’s potential dosing profile with Johnson & Johnson’s SPRAVATO, saying the latter may require roughly 25 to 50 administrations per year. She said the Compass data suggest efficacy in TRD could be achieved with between two and four annual doses, though the company’s statements reflect results from its clinical program and are subject to regulatory review.
Regulatory Path and Potential Launch
Compass has received a National Priority Voucher, which Nath said establishes an FDA target of approval in 60 days or less after acceptance of an application, though he emphasized that it is a target rather than a commitment. The voucher has also altered the company’s interactions with the agency, he said, with information requests, draft-label discussions, a Risk Evaluation and Mitigation Strategy framework, an eight-factor analysis and inspections already underway.
Nath said Compass expects a standard 60-day acceptance period after completing its submission. The company has said it expects a potential launch in the first half of 2027 and plans to be launch-ready by the end of 2026.
A key variable is rescheduling of psilocybin after any FDA approval. Englebert said the Drug Enforcement Administration has up to 90 days by statute to reschedule a Schedule I drug following FDA approval. She added that Compass has worked with states and that states representing about 93% of the U.S. population are positioned to reschedule within 30 days of federal action.
Commercial Infrastructure and Reimbursement
Levine said Compass expects existing interventional psychiatry centers that deliver multi-hour treatments, including SPRAVATO and transcranial magnetic stimulation, to have much of the infrastructure necessary to administer COMP360. These sites generally already have appropriate rooms, multidisciplinary clinical teams and capacity for monitored treatments, he said.
Compass is also pursuing reimbursement preparation. Levine said the company intends to seek a J-code for the drug and has applied for Category III Current Procedural Terminology codes specific to psychedelic treatment administration. The codes are intended to capture clinician work and practice expenses associated with observation, controlled-substance handling and other requirements. Compass expects to deploy reimbursement teams to help sites use the codes following a potential approval.
PTSD Program Advances
Beyond TRD, Compass is advancing COMP360 in post-traumatic stress disorder. Nath said the company’s open-label Phase II study in 22 patients was principally designed to assess safety, given concerns that the psychedelic experience could trigger adverse events in PTSD patients.
According to Nath, Compass did not observe those safety concerns and saw what he characterized as substantial efficacy, including remission in nearly 80% of participants at 12 weeks. The company has started a 300-patient late-stage PTSD study with three arms and two fixed doses. Nath said Compass hopes the trial could serve as a single registrational study, although he noted that determination would ultimately be subject to regulatory review.
Englebert said PTSD represents a significant unmet need, citing an estimated patient population of about 13 million people, approximately 60% of whom are women and 15% of whom are veterans. Nath also identified substance-use disorders, particularly alcohol-use disorder, as a possible future area of interest, while stressing that the company has made no commitments to pursue that indication.
About Compass Pathways (NASDAQ:CMPS)
Compass Pathways plc (NASDAQ: CMPS) is a biotechnology company developing novel treatments for mental health conditions. The company’s primary focus is psilocybin therapy, which combines a proprietary investigational formulation with psychological support delivered by trained therapists.
Its lead candidate, COMP360, is a synthetic crystalline formulation of psilocybin being studied primarily for treatment-resistant depression. Compass Pathways has conducted mid- and late-stage clinical trials evaluating COMP360 and has also investigated its potential use in other difficult-to-treat psychiatric conditions, including post-traumatic stress disorder and anorexia nervosa.
