Compass Pathways Eyes 2027 COMP360 Launch as FDA Review Advances

Key Points

• Compass Pathways expects to submit COMP360’s new drug application in the fourth quarter, potentially enabling a U.S. launch for treatment-resistant depression in the first half of 2027. The FDA is conducting a rolling review, with the therapy’s draft label and risk-mitigation framework already under consideration.
• Phase III trials produced statistically significant depression improvements, with some patients responding within 24 hours and about 40% responding after two doses. Reported side effects, including nausea, headache and fatigue, were generally transient.
• Compass anticipates an initial regimen of two doses at least three weeks apart, followed by physician-directed redosing two to four times annually. The company plans to leverage existing SPRAVATO treatment centers and is also advancing a potentially registrational Phase IIb/III study of COMP360 for PTSD.

Compass Pathways NASDAQ: CMPS expects to complete its new drug application submission for COMP360, its investigational psilocybin treatment for treatment-resistant depression, in the fourth quarter, with a potential U.S. launch in the first half of 2027, executives said at the Morgan Stanley Global Healthcare Conference.

Chief Executive Officer Kabir Nath said the company has a rolling submission and rolling review underway with the U.S. Food and Drug Administration. Compass has received breakthrough therapy designation and expects to receive a Commissioner's National Priority Voucher, which Nath said has increased the level of interaction with the agency.

“We actually have a draft label already under review. The REMS framework is under review,” Nath said, referring to the Risk Evaluation and Mitigation Strategy program that could govern administration of the therapy. He added that Compass has submitted its eight-factor analysis related to rescheduling and that inspections were beginning.

Nath said the company expects the FDA process to maintain the same standards applied to other psychiatric medicines, despite the expedited engagement. He said Compass does not yet know whether the agency will use a standard 60-day filing acceptance process or issue a six-month PDUFA target date after the rolling review is complete.

Phase III program and treatment-resistant depression market

Compass is developing COMP360 for treatment-resistant depression, or TRD, which the company defines as depression following failure of two antidepressants. Chief Commercial Officer Lori Englebert said approximately 4 million of the 13 million U.S. patients receiving drug treatment for major depressive disorder have TRD.

Englebert contrasted the TRD market with the broader major depressive disorder market, noting that there are 55 approved products used annually for MDD but only one product specifically indicated for TRD: Johnson & Johnson’s SPRAVATO.

Compass’ Phase III program included two studies. Nath said COMP005 evaluated a single 25-milligram dose of COMP360 against placebo and was designed in part to establish a safety baseline. COMP006 evaluated 25-milligram, 10-milligram and 1-milligram doses, with two fixed doses administered three weeks apart. The 1-milligram dose was intended to provide some subjective effects rather than serve as an inert placebo, while the 10-milligram dose was intended to help assess dose response and blinding.

Both studies used a six-week primary endpoint and remained blinded through 26 weeks, Nath said. He said the trials showed statistically significant results on the primary endpoint, with a difference of just under four points in change from baseline on the Montgomery-Åsberg Depression Rating Scale, or MADRS.

Nath said the company observed rapid onset, with patients who responded potentially showing improvement within 24 hours. He said roughly one-quarter of patients had a clinically meaningful response following one administration, while approximately 40% responded after two doses given three weeks apart. Compass also reported durability through 26 weeks and said data from COMP005 extending to 52 weeks indicated that a potential third dose had efficacy comparable with earlier doses.

According to Nath, the most common adverse events were generally transient and occurred on the dosing day, including nausea, headache and fatigue. He said these events typically resolved within one or two days.

Dosing burden, sites and reimbursement

Englebert said Compass expects its eventual label to specify two initial doses given at least three weeks apart, although physicians would decide whether a patient needs the second dose. She said the company anticipates patients could require two to four doses annually, with redosing at physician discretion.

She compared that potential schedule with SPRAVATO, which she said is administered twice weekly during the first month, weekly in the second month and then weekly or every other week for ongoing maintenance. Nath said that, because of that treatment burden, many SPRAVATO patients do not continue beyond seven or eight months.

Compass sees existing SPRAVATO treatment infrastructure as a potential starting point for COMP360. Englebert said there are approximately 8,500 sites able to administer SPRAVATO and that those centers already have the rooms, staffing and monitoring capabilities needed for COMP360. She said such sites are growing by about 500 per quarter and are not currently at capacity.

Only about 2% of the TRD population is treated with SPRAVATO and another 2% receives electroconvulsive therapy or transcranial magnetic stimulation, Englebert said. Compass plans to focus on newly identified TRD patients rather than targeting patients who are stable on SPRAVATO.

On reimbursement, Englebert said providers should not be disadvantaged relative to administering SPRAVATO because they can initially use the same general evaluation and management billing codes. Compass plans to deploy a field reimbursement team at launch and encourage providers to attach Category III CPT codes, which could help support an eventual transition to Category I codes.

Launch preparation and PTSD program

Following a potential approval, federal rescheduling would be required because psilocybin is currently a Schedule I substance. Englebert said that process could take from one to 90 days after approval. States would then need to reschedule the product before it could be shipped and prescribed in those jurisdictions.

She said Compass has worked with states and expects that states representing 93% of the U.S. population would reschedule within 30 days of federal action. The company expects a measured initial launch as it focuses on provider reimbursement, site readiness and patient education, followed by broader adoption as sites gain experience.

Compass is also advancing a Phase IIb/III study of COMP360 in post-traumatic stress disorder. Englebert estimated the PTSD population at about 13 million patients and said the last approved product in the indication was introduced 25 years ago. Nath said the study uses two fixed doses and has an eight-week primary endpoint using the CAPS-5 assessment, followed by a blinded period through 12 weeks and open-label follow-up for one year.

Nath said Compass believes the study could be registrational, though the company has not provided enrollment or timing guidance.

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.

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