Compass Pathways Targets Q4 COMP360 NDA Completion, Eyes 2027 Launch

Compass Pathways remains on track to complete its rolling NDA submission for COMP360 in Q4, with a potential U.S. launch targeted for 2027 or the first half of the launch year, depending on FDA review and controlled-substance rescheduling. Phase III extension data supported COMP360’s repeat-treatment approach, showing rapid, clinically meaningful and potentially durable improvements in treatment-resistant depression, with a generally safe and well-tolerated profile. The company is preparing commercial operations by targeting interventional psychiatry centers, expanding its field team and developing reimbursement support, while federal and state rescheduling remain key launch prerequisites.

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.

Chief Patient Officer Steve Levine discussed top-line results from Part C of the COMP005 Phase III extension study, which evaluated COMP360 in adults with treatment-resistant depression. The original study compared a 25-milligram dose of COMP360 with placebo in patients with major depressive disorder who had failed at least two treatments during their current depressive episode. 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.

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 ...