Race for first FDA-approved psychedelic intensifies

The competition to secure the first U.S. Food and Drug Administration approval for a psychedelic therapy has accelerated following the submission of a New Drug Application by the non-profit Usona Institute. The organization is seeking approval for its psilocybin candidate intended for the treatment of major depressive disorder.

Compass Pathways, a biotechnology firm developing its own psilocybin candidate known as COMP360 for treatment-resistant depression, announced on Nov. 3, 2026, that it expects to file its own application within two weeks. Both entities hold Commissioner’s National Priority Vouchers, which are designed to expedite the regulatory review process to approximately 1–2 months once the applications are accepted.

Following reports of the Usona Institute's filing, shares of Compass Pathways experienced volatility, declining between 28% and 35% on Nov. 2, 2026, as investors assessed the changing competitive landscape. The market shift comes after an April 2026 executive order signed by President Trump directed the FDA to accelerate the review of psychedelic treatments for mental health conditions.

Compass Pathways CEO Kabir Nath stated that the company is moving with urgency to finalize its submission and is preparing for a potential U.S. launch in the first half of 2027. If the current regulatory timelines are maintained, the FDA could reach a decision regarding the applications for either organization by late 2026 or early 2027.