Compass Pathways expects to finish its psilocybin drug application in late 2026, with a launch aimed for 2027

What happened?

In its second-quarter results, filed with the SEC and dated August 5, 2026, Compass Pathways said: "Rolling submission and initial review are underway, with some modules of the NDA submitted." An NDA is a new drug application, the filing a company makes to ask the FDA to approve a drug. Compass said it is "on track to complete all modules in Q4" 2026.¹

The company's release says the FDA agreed to a rolling submission and review in April 2026, and that COMP360 holds a National Priority Voucher, which Compass says "has the potential to accelerate filing review time to be completed within 1-2 months." COMP360 also holds Breakthrough Therapy designation.¹

Compass expects a commercial launch in the first half of 2027, subject to FDA approval and then DEA rescheduling. Its filing says the drug "must be rescheduled before commercializing COMP360 psilocybin in the U.S."¹ The company also says about 90% of the US patient population lives in states that intend to reschedule within 30 days after federal DEA action.¹

The release cites two Phase 3 trials: 39% of participants in COMP006 and 25% in COMP005 reached what the company calls a clinically meaningful reduction (more than 25%) on the MADRS depression scale at week 6, with the benefit maintained on average through at least week 26.¹ These are the company's figures; the FDA has not yet ruled on them.

Why does it matter if you're looking for a mushroom dispensary?

If COMP360 is approved, it will be a prescription drug, not mushrooms. COMP360 is a synthetic form of psilocybin made by a drug company.² Approval and rescheduling would apply to that product, and psilocybin mushrooms would stay in Schedule I. The FDA's September 2026 hearing on psychedelic drugs was framed around drugs given "in supervised and supportive settings," which our post on the FDA hearing explains.

Federal moves on psilocybin medicines don't change the law for mushrooms. Executive Order 14401 tells the Attorney General to review any Schedule I product that has completed Phase 3 trials for a serious mental health disorder, so that rescheduling, if appropriate, can follow quickly after FDA approval, but it does not name psilocybin and does not mention retail sale.³ Until then, the lawful options are federal clinical trials and, under state law alone, licensed sessions in Oregon and Colorado and narrow patient pilots, covered in our guide to licensed psilocybin centers. Federal and state law are set out in are mushroom dispensaries legal?

What happens next?

Compass said it expected to submit the last modules in the fourth quarter of 2026. As of November 2, 2026, we had not found an announcement that the application was complete. After that come the FDA's review and, if the drug is approved, a DEA rescheduling decision; neither has a date. We'll update this post when the filing is complete or the FDA acts.