Compass says its psilocybin drug application will be complete by year-end

What Compass says about its FDA filing

In a July 7, 2026 filing with the Securities and Exchange Commission, Compass said "a rolling New Drug Application, or NDA, submission and initial review with the U.S. Food and Drug Administration, or FDA, is underway and final submission remains on track to be completed in Q4, 2026."¹ A rolling submission lets a company send its application in parts. The FDA agreed to that in April 2026, and on Aug. 5 Compass said "some modules of the NDA" were in, with the rest due in the fourth quarter.²

As of Nov. 2, Compass hadn't reported the application complete; its latest 8-K report is dated Aug. 5, 2026.⁶

Compass also holds an FDA national priority voucher for COMP360, which it says "has the potential to accelerate filing review time to be completed within 1-2 months."² The FDA's own notice says a voucher is not "an FDA determination of safety or effectiveness" and is no "substitute for marketing approval."⁷ Compass expects a launch in the first half of 2027, "subject to FDA approval and following Drug Enforcement Administration, or DEA, rescheduling."¹

How many people were in the trials?

Compass's application draws on two pivotal Phase 3 trials, COMP005 and COMP006.¹ ClinicalTrials.gov lists 572 people enrolled in the larger one, COMP006.⁴ Compass's July 7 SEC filing counts 581 dosed participants in that trial and describes findings "in nearly 600 patients."¹ The records don't explain the gap, so we give both. The smaller trial, COMP005, enrolled 258 people and was completed April 15, 2026.⁵

COMP006 compared two administrations of COMP360 at 25 mg or 10 mg with a 1 mg comparator.⁴ Compass reports that 39% of the 25 mg arm had a drop of 25% or more on a standard depression scale (MADRS) by week 6 and kept it, on average, through week 26, versus 25% after a single administration in COMP005.¹

Its presentation counts serious adverse events through week 26 in 17 of 296 people in the 25 mg arm, 5 of 142 at 10 mg and 9 of 143 at 1 mg. One suspected suicide in the 25 mg arm was judged by the investigator as not related to treatment.³ These are company figures: neither trial had posted results on ClinicalTrials.gov as of Nov. 2.⁴⁵

Which Florida clinics took part?

COMP006's registry record lists nine Florida sites: Central Miami Medical Institute in Miami, Behavioral Clinical Research in Miami Lakes, Innovative Clinical Research in Lauderhill, Health Synergy Clinical Research in West Palm Beach and Okeechobee, CNS Healthcare and APG Research in Orlando, and the University of South Florida and Stedman Clinical Trials in Tampa.⁴ COMP005 listed two Orlando sites and two sites recorded under Tampa.⁵ Neither trial is recruiting.

Why it matters in Miami

If the FDA approves COMP360, part of the evidence will come from a trial that listed clinics in Miami-Dade, Broward and Palm Beach among its sites.⁴ Approval alone wouldn't change Florida law, though. Psilocybin and psilocyn are listed in Florida's Schedule I at s. 893.03(1)(c)33. and 34.⁸ They stay there until the Legislature changes the list or the Attorney General moves them by rule under s. 893.0355, which says the Attorney General "shall give great weight" to federal rescheduling.⁹

Compass says about 90% of U.S. patients "live in states that intend to reschedule within 30 days after Federal DEA" action, without naming the states.² An approval would cover Compass's synthetic product, not mushrooms, and the company expects it to be given at existing treatment centers that offer multi-hour treatments.² Until then, Floridians can receive psilocybin legally in the state as screened volunteers in registered trials. Our Florida trials tracker lists them, and Compass's PTSD study is recruiting at a Miami site.