Compass Pathways Eyes 2027 COMP360 Launch as FDA Filing Nears

Compass Pathways expects to complete its FDA submission for COMP360 in the fourth quarter and is targeting a commercial launch for treatment-resistant depression in the first half of 2027, pending approval and regulatory rescheduling of psilocybin.

COMP360 could be administered only two to four times annually, with an anticipated six-hour monitoring period and a potential annual cost broadly comparable to SPRAVATO’s $50,000–$65,000 range.

The company is preparing treatment sites, reimbursement programs and a commercial team for a gradual rollout, while advancing a late-stage PTSD trial and exploring additional opportunities including alcohol-use disorder.

Compass Pathways NASDAQ: CMPS said it expects to complete its rolling New Drug Application submission for its synthetic psilocybin treatment, COMP360, in the fourth quarter and continues to target a potential commercial launch for treatment-resistant depression in the first half of 2027.

Speaking at Deutsche Bank’s Healthcare Summit, Chief Financial Officer Teri Loxam said the company has completed two Phase III trials in treatment-resistant depression, or TRD, that were “highly statistically significant.”

The company is also conducting a late-stage trial of COMP360 in post-traumatic stress disorder, which it views as a potential follow-on indication.

The company is using a rolling submission and review process with the FDA and received a Priority Review Voucher in April.

Chief Commercial Officer Lori Englebert said the voucher increases the frequency of interactions with the FDA and provides for a target review time of one to two months after the NDA is completed.

However, she said there remains uncertainty over whether the agency will also take up to 60 days for its acceptance period.

Following a potential FDA approval, COMP360 would require rescheduling by the Drug Enforcement Administration because psilocybin is currently a Schedule I substance.

Englebert said the DEA is required by statute to reschedule a product with an approved medical use within 90 days, although a February executive order could potentially accelerate that process for psychedelic therapies.

She said Compass has also been working to prepare states to complete their own rescheduling processes within 30 days of DEA action.

Chief Patient Officer Dr. Steve Levine said Compass expects a broad label for the treatment of TRD.

Based on the company’s Phase III studies, he said a potential label could describe treatment initiation as two doses administered no sooner than three weeks apart, followed by further dosing at clinician discretion or as clinically indicated.

Levine said patients could receive COMP360 two to four times annually, with some patients potentially needing fewer doses and others requiring additional treatment.

He contrasted this with Johnson & Johnson’s SPRAVATO, which he said is generally administered 25 to 50 times per year for TRD patients.

Compass expects a Risk Evaluation and Mitigation Strategy, or REMS, comparable to the program used for SPRAVATO.

Levine said the anticipated key distinction would be the monitoring period: Compass expects six hours of monitoring for COMP360, compared with two hours for SPRAVATO.

Englebert said approximately 8,000 sites are currently certified to administer SPRAVATO, with the number growing by roughly 500 sites per quarter.

She said Compass has begun making contingent offe...