Compass says its psilocybin application should be complete in late 2026

What did Compass say?

In its second-quarter results, filed with the SEC on Aug. 5, Compass said the rolling submission of its new drug application (NDA) and the FDA's initial review were under way, with "some modules of the NDA submitted and on track to complete all modules in Q4." It expects a commercial launch in the first half of 2027, "subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling."¹

Other points from the filing:¹

• The FDA granted Compass's request for a rolling submission and review in April.
• COMP360 holds a national priority voucher, which Compass says could bring the review of its filing down to 1 to 2 months. The FDA's own hearing notice confirms it issued a voucher in April 2026 for psilocybin in treatment-resistant depression.²
• Compass had $433.3 million in cash and cash equivalents on June 30, 2026, which it expects to fund operations into 2028.
• A late-stage trial of COMP360 for PTSD is under way.

These are the company's forecasts, labeled in the filing as forward-looking statements. Compass describes COMP360 as an investigational treatment; no psilocybin medicine has FDA approval.¹

Has the application been completed?

We can't confirm it. Compass announced its July and August updates in 8-K filings with the SEC, and its filing list shows no 8-K after Aug. 5, 2026; the most recent filing as of Nov. 2 is an Oct. 28 ownership report by an outside holder.³ The fourth quarter runs through Dec. 31, so the target date hasn't passed. We'll update this post when Compass or the FDA says the submission is complete.

What would have to happen after an approval?

Two federal steps, in order. First the FDA decides whether to approve. The FDA's psychedelic trial guidance says that once a drug is approved, and so has an accepted medical use, it is placed in Schedule II, III, IV or V according to its abuse potential.⁴ That rescheduling is the DEA's job. Executive Order 14401 directs the Attorney General, consulting HHS, to "initiate and complete review" of any Schedule I product that finishes Phase 3 trials for a serious mental health disorder, so that rescheduling, if appropriate, can proceed "as quickly as practicable for such specific products" that are approved.⁵ The order speaks of specific approved products, not of psilocybin in general.

Compass also says it is engaging with "state-level stakeholders" on rescheduling after approval, and that about 90% of the U.S. patient population lives in states that intend to reschedule within 30 days after the DEA acts.¹ The company doesn't name those states.

How would Nevada follow? NRS 453.2182

Nevada has a standing rule for this. Under NRS 453.2182, if a substance is designated, rescheduled or deleted under federal law, Nevada's Board of Pharmacy "shall similarly treat the substance" once 60 days have passed after the federal final order is published in the Federal Register.⁶ The steps:

• No objection within the 60 days: the Board adopts a final regulation matching the federal change, without the findings it would normally have to make.
• An objection from the Board or any interested party: the Board publishes notice of it, its action is put on hold, and it must make its own determination under NRS 453.146 before adopting a regulation.

So Nevada's statute sets a 60-day wait, not 30, and it tracks whatever the federal order covers. Until both federal steps happen, psilocybin stays on Nevada's Schedule I list, NAC 453.510,⁷ and possession remains a crime; our Nevada law page has the penalties. The full sequence is laid out in when psilocybin could be legal in Nevada.

COMP360 is already being studied in Nevada: Compass's PTSD trial lists a Las Vegas site that was recruiting when we checked on Nov. 2.⁸ Our therapy and trials guide explains how trials work.