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The FDA said Friday it has issued new fast-track vouchers to three psychedelic companies, and its selections have come as a “surprise” to Wall Street. In an unusual move, the agency didn’t name the sponsors or their programs in its announcement, but said the Commissioner’s National Priority Vouchers are going toward companies that are advancing psilocybin for treatment-resistant depression, methylone for post-traumatic stress disorder and psilocybin for major depressive disorder. Compass Pathways confirmed it was one of the recipients in a press release issued hours later. A source familiar with the announcement told Endpoints News that the other two recipients are Transcend Therapeutics and the Usona Institute. Transcend declined to comment, and Usona did not immediately respond to a request for comment. Compass was widely anticipated to be a CNPV recipient after President Donald Trump signed an executive order last week to “accelerate treatments for serious mental illnesses.” Compass’ psilocybin-based treatment-resistant depression drug, COMP360, already has positive Phase 3 data as well as breakthrough therapy designation. But the other choices are a little “surprising,” Stifel analyst Paul Matteis told Endpoints in an interview. Transcend’s methylone program, called TSND-201, is in Phase 3 development for PTSD. The biotech is being acquired by Otsuka. Meanwhile, the Usona Institute is running a Phase 3 trial of psilocybin in major depressive disorder. Last week, Matteis wrote that Definium Therapeutics was an “obvious” choice for a CNPV thanks to “outstanding” Phase 2 data for its generalized anxiety disorder treatment, called DT120, which is a formulation of LSD. But that compound didn’t appear on Friday’s list. DT120 is approaching a Phase 3 readout later this year. Definium CEO Robert Barrow told Endpoints on Friday the company had “absolutely expressed interest” in a CNPV. “For the companies that applied for and received vouchers, presumably giving them some excitement about a faster path forward, that’s great,” Barrow said. “We believe we’ve got a drug that has potential to have as much or more impact than anyone.” In addition to encouraging CNPVs for psychedelics, Trump’s executive order also contains provisions to match state investments in psychedelic research and instructs the FDA and DEA to expedite rescheduling of some of these drugs when appropriate once they release Phase 3 data, rather than after receiving FDA approval. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here. Max Bayer contributed reporting.

iStock/ bestdesigns While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute. The FDA followed up President Donald Trump’s April 18 executive order on Friday, awarding Commissioner’s National Priority Vouchers to three companies developing psychedelic therapies. The FDA did not disclose the specific companies to receive Commissioner’s National Priority Vouchers (CNPVs) in its Friday morning release and declined to comment on the record when contacted by BioSpace . However, it did say in its Friday release that the recipients are developing psilocybin for treatment-resistant depression (TRD), psilocybin for major depressive disorder (MDD) and methylone for post-traumatic stress disorder (PTSD). Shortly after the FDA announcement, Compass Pathways issued a press release announcing that it had received one of the vouchers for its psilocybin-based candidate COMP360 for TRD. The FDA also approved Compass’ new drug rolling review request in post-traumatic stress disorder (PTSD). Meanwhile, the other two voucher recipients remain undisclosed, though a few companies match up with the agency’s descriptions. Transcend Therapeutics, for example, is developing methylone-based TSND- 201 for PTSD. TSND-201 received the agency’s Breakthrough Therapy designation in July 2025—a requirement stated in the president’s executive order for the three expected CNPVs. At the time, Transcend was in the process of initiating a Phase 3 trial. There’s also Usona Institute, which received the FDA’s Breakthrough Therapy designation in 2019 for its psilocybin-based candidate designed to treat MDD. Notably, none of the listed products match those in development at Definium Therapeutics, which was widely believed to be in the running for one of the priority review vouchers. Definium’s lead candidate DT120 is a pharmaceutically optimized formulation of lysergide (LSD) D-tartrate in Phase 3 trials for MDD and generalized anxiety disorder. The company has an earlier-stage MDMA-based asset in Phase 2 development for autism spectrum disorder. Psychedelics Trump throws support behind psychedelics with executive order A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets. April 20, 2026 · 2 min read · Tristan Manalac Read more Friday’s update follows an executive order signed by Trump last Saturday morning in the Oval Office. The order, which is aimed at accelerating the development of and facilitating broader access to psychedelic therapies for serious mental health conditions, instructed the FDA to grant three CNPVs to psychedelics in development that also hold Breakthrough Therapy designation. The priority voucher program, announced in June 2025, aims to shorten review times for products that meet national priorities down to 1–2 months from the usual 10–12 months. “There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat,” Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a statement on Friday. “At the FDA we are showing our support of investigating the safety and efficacy of this class of drugs through today’s actions.” While the reaction to this new psychedelic therapies push has been largely positive, some experts have questioned, in particular, its origin. The executive order came about after Joe Rogan sent Trump information on the benefits of ibogaine—a particularly tricky psychedelic—for opioid use disorder, the pundit said during Saturday’s signing. Rogan recalled Trump’s response: “Sounds great. You want FDA approval, let’s do it.” Holly Fernandez Lynch, associate professor of Medical Ethics and Law at the University of Pennsylvania, pointed to this as a particular point of concern. “What Trump was saying around the executive order during the press conference was kind of mind blowing,” she told BioSpace on Monday. “Like this idea that his buddies could just send him a text and he’ll offer them FDA approval is not acceptable.” In addition to the CNPVs, the FDA intends to release final guidance “imminently” to sponsors regarding the development of psychedelics. “Designing clinical trials to evaluate serotonin-2A agonists [a class to which psychedelics belong] and related products presents unique scientific and methodological challenges,” according to the release. Psychedelics Trump’s psychedelics push a mixed blessing for neuropsychiatric companies, patients With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field? April 22, 2026 · 8 min read · Heather McKenzie Read more