Compass Pathways (NASDAQ:CMPS) executives said the company remains on track to complete its rolling New Drug Application submission for COMP360 in the fourth quarter, while preparing commercial infrastructure for a potential U.S. launch following FDA approval and federal rescheduling.
Speaking at TD Cowen’s 6th Annual Neuropsychiatry Summit, CEO Kabir Nath said the company has the data required for its submission and is completing integrated summaries, particularly its integrated safety summary, from two Phase III studies. Nath said a first-half launch window remains realistic, though timing will depend on FDA review and subsequent controlled-substance rescheduling.
Extension data supports repeat-treatment approach
Levine said participants in the open-label Part C portion could receive a single 25-milligram dose. Patients previously assigned to COMP360 who received a second or third treatment showed a similarly rapid response, greater depth of response, and durability, he said. Patients who had previously received placebo and then received their first COMP360 dose showed rapid and clinically meaningful reductions in Montgomery-Åsberg Depression Rating Scale, or MADRS, scores.
According to Levine, the data reinforced an emerging profile of immediate benefit among responders that could remain durable through 52 weeks with one, two or three treatments. He added that the treatment has shown a generally safe and well-tolerated profile in the data discussed.
FDA review and rescheduling remain key variables
Nath said Compass is receiving FDA information requests, indicating that portions of its rolling application are under active review. However, he cautioned that approval timing remains uncertain because there are limited precedents for the type of rolling NDA process involved.
The FDA could take up to 60 days to accept the completed filing, Nath said, and a 30- to 60-day approval goal discussed by agency officials is a target rather than a commitment. The company expects it could provide a more refined timing range as it completes the filing and continues discussions with the agency.
Chief Commercial Officer Lori Englebert said COMP360, currently a Schedule I substance, would need to be rescheduled after FDA approval before it could be prescribed and administered. She said the Drug Enforcement Administration typically takes about 90 days to reschedule a product, although an executive order issued in April called for closer coordination between the FDA and controlled-substance staff that could potentially shorten the process.
Englebert said Compass has already submitted its eight-factor analysis to the FDA, which could support the rescheduling review. She added that state-level rescheduling is also required, but said approximately 93% of the U.S. population lives in states expected to reschedule within 30 days of federal action. The company said major commercial geographies, including the top 10 states, are among states positioned to act promptly.
Management’s base-case expectation is for Schedule III status, Nath said. Levine said the operational requirements for treatment sites would be broadly similar under Schedule II or Schedule III because COMP360 would be securely stored and administered on site rather than dispensed through retail pharmacies.
Commercial build-out targets interventional psychiatry centers
Englebert said Compass expects to be launch-ready by the end of the year and has substantially completed its headquarters staffing build-out. The company is making contingent offers to sales representatives and is hiring field reimbursement personnel, she said.
The company plans to focus initially on interventional psychiatry centers, including sites that administer Spravato. Englebert said about 80% of Spravato volume is written at roughly 20% of sites, or fewer than 2,000 centers, while the broader network of treatment sites has continued expanding.
Compass plans to use a tiered field-force model, with more frequent engagement at sites considered most likely to prescribe early. The company also expects to reach referring providers, including psychiatrists and certain primary-care physicians treating large populations of patients with treatment-resistant depression.
Levine said existing interventional sites generally have the rooms, monitoring capabilities and staff necessary for multi-hour, in-office treatments. He said Compass has supported training programs through grants and has made training materials available to organizations developing psychedelic-treatment education. The company expects authorized site representatives to attest through its REMS process that personnel involved in COMP360 treatment have been appropriately trained.
Reimbursement strategy includes CPT code transition
Executives also addressed reimbursement for the provider monitoring and support time associated with treatment. Levine said Compass previously secured Category III Current Procedural Terminology codes and expects those codes to remain Category III at launch.
Englebert estimated that conversion to Category I codes could take about 18 months, depending on demand and review timing. In the interim, treatment sites are expected to use reimbursement codes currently used for Spravato, she said. Compass believes Category I codes could ultimately provide more favorable hour-by-hour valuation for provider time.
The company plans to deploy field reimbursement specialists to help sites understand available coding options and report services appropriately. Englebert also said Compass intends to offer patient support services and work to reduce financial and operational barriers for both patients and treatment sites during the early launch period.
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.
