Reported expectations for COMP360 pricing: about $50,000 to $65,000 a year, a derived per-dose figure, who might pay, and why no list price exists yet.
The reported COMP360 cost is about $50,000 to $65,000 a year. Compass Pathways management gave that expectation at an investor summit, according to Investing.com's September 17, 2026, report. No list price, FDA label or coverage decision exists yet for COMP360, Compass Pathways' proprietary formulation of synthetic psilocybin for treatment-resistant depression (TRD).
Compass Pathways management has said COMP360 is expected to be priced at about $50,000 to $65,000 a year. The figure comes from an Investing.com summary of management remarks at an investor summit, published September 17, 2026. The report describes the range as on par with Spravato.
The $50,000 to $65,000 range is a projection. It is not a list price, and Compass Pathways had not set a list price for COMP360 as of October 11, 2026. Compass Pathways ties its launch to FDA approval and DEA rescheduling, so no patient can be quoted this figure today.
Management did not give a per-dose price. The chief executive officer said, "we will price on that annualized divided by three." Applying that formula, $50,000 divided by three is about $16,700, and $65,000 divided by three is about $21,700.
Rounded, the derived range is about $17,000 to $22,000 per dose. That division uses only the reported annual range, and Compass Pathways has not published a per-dose figure of its own.
The Investing.com article is a third-party summary of the summit transcript. The pricing words therefore reach readers secondhand, through a reporter's summary of what management said.
Management said the per-dose price will be the annual figure divided by three. Management described expected average use as 2 to 4 doses a year, with 3 as the working average, according to the Investing.com report. The Phase III trial COMP006 tested up to four doses per year.
Investing.com also reported that the initial treatment may be two doses at least three weeks apart, with more doses at a clinician's discretion. An FDA-approved label would set the exact regimen. No approved label for COMP360 exists as of October 11, 2026.
A final list price would change every number in this section. So would an approved label with a different dosing schedule, and neither has been published.
No insurance coverage policy exists for COMP360, and every coverage point reported so far is a company statement or plan. After the 26-week COMP005 data, management described payer feedback as "overwhelmingly positive," according to Investing.com. Payers reportedly focus on efficacy, rapid onset and durability.
That description is management's characterization of conversations with payers. The Investing.com report does not say any payer has agreed to cover COMP360.
Compass Pathways has new Current Procedural Terminology (CPT) codes in Category III and plans to move to Category I codes after approval. Compass Pathways also intends to pursue a J-code to support buy-and-bill economics. Management noted that about 35% to 40% of Spravato use is currently buy-and-bill.
Spravato is the product named as the pricing comparison in the Investing.com report. For how that drug is paid for today, read what Spravato costs with insurance. For a related billing question, see ketamine therapy insurance coverage.
Compass Pathways' own second quarter 2026 results release lists, among its forward-looking-statement caveats, that reimbursement efforts may be unsuccessful. At approval, Compass Pathways says its focus will include assistance with reimbursement and patient support. The same release names site training, education and Risk Evaluation and Mitigation Strategy (REMS) certification as part of that focus.
No COMP360 list price has been set, and FDA approval, DEA rescheduling and state rescheduling are all still pending. Compass Pathways' August 5, 2026, release says the rolling NDA submission and initial review are underway, with some modules submitted. Compass Pathways says it is on track to complete all modules in the fourth quarter of 2026.
In April 2026, the FDA granted Compass Pathways a rolling submission and review request. The FDA granted Breakthrough Therapy designation in 2018. That designation is a regulatory status and is not a finding that COMP360 works.
Compass Pathways was also awarded a National Priority Voucher for COMP360 in TRD. Compass Pathways says the voucher has the potential to shorten FDA review time to 1 to 2 months.
After any FDA approval, DEA rescheduling can take up to 90 days by statute, management said, adding that an executive order could shorten that period. Compass Pathways' release describes a White House executive order on psychedelic treatments that directs the DEA to start and complete review of a psychedelic treatment that has completed Phase 3.
Management said state rescheduling would follow within about 30 days of federal action. Compass Pathways says approximately 90% of the U.S. patient population lives in states that intend to reschedule within 30 days after DEA action.
Compass Pathways expects commercial launch in the first half of 2027, subject to FDA approval and following DEA rescheduling. Until those steps finish, the $50,000 to $65,000 range remains a projection.
The reported figures describe the drug program as Compass Pathways management described it, and no patient can pay them today. COMP360 is not FDA-approved as of October 11, 2026. Outside an authorized clinical trial, there is no lawful clinical access to COMP360.
Neither source publishes a patient out-of-pocket amount, a copay or a total that includes clinic visits. A reader comparing the $50,000 to $65,000 range with other bills has only a drug-price expectation to work with.
Psilocybin is a Schedule I controlled substance under federal law. The Controlled Substances Act guide covers federal scheduling, and the legal status by state tool and are mushrooms legal guide cover state rules.
For background on the compound, read the psilocybin guide and the psilocybin for depression research overview. To follow when a COMP360 price becomes official, read Compass Pathways' quarterly results starting with the second quarter 2026 release, and search authorized studies with the clinical trial finder.
Compass Pathways management has said it expects COMP360 to be priced at about $50,000 to $65,000 a year, according to a September 17, 2026, Investing.com report. Dividing that range by three doses gives about $17,000 to $22,000 per dose, a figure derived by simple arithmetic. Compass Pathways has not published a list price or a per-dose price.
No. The $50,000 to $65,000 range is a reported expectation from management remarks at an investor summit. COMP360 is not FDA-approved as of October 11, 2026, and no list price exists.
No approved label sets a COMP360 regimen yet. Management described expected use as 2 to 4 doses a year, with 3 as the working average, and the Phase III COMP006 trial tested up to four doses per year. Investing.com also reported that the initial treatment may be two doses at least three weeks apart, with more at clinician discretion.
No coverage policy exists for COMP360. Management described payer feedback after the 26-week COMP005 data as overwhelmingly positive, and Compass Pathways plans billing codes that include a J-code. Compass Pathways' own release cautions that reimbursement efforts may be unsuccessful.
Compass Pathways expects commercial launch in the first half of 2027, subject to FDA approval and following DEA rescheduling. Compass Pathways expects to complete its rolling NDA submission in the fourth quarter of 2026. Management said DEA rescheduling can take up to 90 days by statute after approval.
Outside an authorized clinical trial, there is no lawful clinical access to COMP360 as of October 11, 2026. COMP360 is not FDA-approved, and psilocybin is a Schedule I controlled substance under federal law.
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