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?
Compass Pathways employees and shareholders woke up Monday morning to find their stock up 25% in premarket trading. Over the weekend, President Donald Trump had provided the psychedelic therapies space with an unexpected gift—an executive order intended to accelerate these treatments to market.
Shares of Compass would continue to climb throughout the day as executives at the New York and London–based biotech—along with peers Definium Therapeutics, Helus Pharma and more—rushed to put out statements in support of the executive order, signed by Trump Saturday morning. The president was joined in the Oval Office by Health Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, podcaster Joe Rogan and several military veterans.
“First and foremost, this is amazing news for patients,” Steve Levine, chief patient officer at Compass, told BioSpace Monday afternoon. “This clearly reflects that President Trump and this administration recognize that there are millions of Americans who are suffering from mental health conditions, that are underserved, that need new, innovative options, and they recognize the potential of emerging psychedelics to meet that need.”
The order instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that fit the criteria of that program, which was first introduced in June 2025 to accelerate review times for products that align with certain national priorities from 10–12 months to 1–2 months. Three of these vouchers will be issued this week, Makary said during the press conference.
“It’s a pretty egregious step for the White House to direct FDA with regard to specific products,” Holly Fernandez Lynch, associate professor of Medical Ethics and Law at the University of Pennsylvania, told BioSpace. “That level of politicization is pretty extreme. . . . The language seems pretty intense.”
Compass, which is closing in on a regulatory application for psilocybin-based COMP360 for post-traumatic stress disorder (PTSD), is widely expected to be one of the CNPV recipients. Notably, COMP360 was reportedly on the shortlist to receive a priority voucher in the first round last fall but ultimately did not make the cut.
Meanwhile, Definium—formerly MindMed—could also receive a priority voucher. The company is gearing up for a trio of Phase 3 data drops in generalized anxiety disorder and major depressive disorder for DT120, an LSD-based therapy that also holds Breakthrough Therapy designation.
By 2027, “DT120 and COMP360 are probably going to be approved,” H.C. Wainwright analyst Patrick Trucchio told BioSpace in February. If these products get vouchers, that timeline could move up dramatically.
Indeed, Makary acknowledged on Saturday that applications for psychedelic therapies are about to come in, “so this is the natural perfect timing for this announcement.”
But Fernandez Lynch fears the executive order will have the opposite effect of its stated intention by raising concerns about how these therapies get to the market. “How terrible would it be for products that are really good to have a hanging cloud over them that maybe it was just politics that supported their approval.”
A nod to real-world evidence
While recent FDA decisions—see Replimune, uniQure and REGENXBIO—are reflective of a more stringent FDA, Makary’s words at the signing of the executive order appeared to be anything but. In fact, the commissioner seemed to be encouraging the use of real-world evidence (RWE).
“There are a lot of medications in medicine where we don’t know exactly how it works, but we see profound results,” Makary said. “If we actually listen to those who experience the therapeutic value, we can learn as a medical field. We just have to listen. The stories of those individuals with dramatic results, that is data, that is scientific data, even from a single individual.”
Makary quickly followed that statement by affirming that randomized trials are needed. “We have to do that because we need to be able to say there’s good support when we recommend these therapeutics.”
Both Compass’s Levine and AtaiBeckley CEO Srinivas Rao emphasized the need for a “thorough review” of their products. “I think there continues to be this focus on the rigor and everything else,” Rao said. “I mean, I don’t think they’re necessarily deviating from that.”
Compass and Definium have conducted “robust clinical studies,” he continued. “The companies themselves are not that interested in corner-cutting. Expeditious review is what we’re really after.”
Two 25-mg doses of COMP360 given three weeks apart elicited a 3.8 point change on a measurement of severity of depressive episodes after 6 weeks of treatment in a Phase 3 trial reported in February. This equated to a “highly statistically significant reduction in symptom severity,” according to Compass’ release at the time.
“Certainly, we want to make sure that we are responding to this obvious call for acceleration, for speeding up, for meeting these needs as quickly as possible,” Levine said. “We still are also committed to a rigorous process and making sure that we have provided sufficient data for the safe evaluation of our product and thorough evaluation of it.”
Compass expects the final data required for its FDA submission to arrive in the third quarter of this year. The biotech is currently working with the FDA on a rolling submission for COMP360 and plans to complete that application in the fourth quarter of this year. As for whether a priority voucher will accelerate this process, Levine told BioSpace at 1:30 p.m. on Monday afternoon, “We are actively evaluating that. We haven’t given updated guidance since this news.”
But the idea of rapid and thorough review is itself a concern for Fernandez Lynch. These rapid reviews are “resource intensive,” meaning other applications could be deprioritized. “I think it’s very important for FDA to be able to make those trade-offs itself based on what it knows about other products that are coming through,” she said—and not the White House.
Aside from priority vouchers, the executive order focused on several points related to accelerating psychedelic therapies. These included expedited rescheduling of the compounds, which analysts have anticipated will delay launches of newly approved psychedelics. The order also addressed funding for research through the Advanced Research Projects Agency for Health and access through the Right to Try Act, which was implemented during Trump’s first term.
The Rogan twist
It’s no secret that psychedelics enjoy broad support within the Trump administration. Both Kennedy and Makary have put their words behind psychedelics. However, Rogan painted a different picture of the timing of the announcement, pointing to the use of ibogaine in overcoming opioid addiction.
In 2024, more than 80,000 people died of opioid overdoses, the pundit said during the signing of Saturday’s executive order, and more than 5 million Americans are currently addicted to opioids. A handful of companies, including AtaiBeckley, are developing ibogaine-based treatments. On Saturday, Makary announced the first Investigational New Drug (IND) clearance for ibogaine. It was unclear at the time what product this IND belonged to, but on Wednesday, Atai subsidiary DemeRX revealed itself as the recipient. The biotech is developing DMX-1001, an oral derivative of ibogaine, called noribogaine intended for alcohol use disorder.
“With one dose of ibogaine, more than 80% of people are free of that addiction. With two doses, it’s more than 90%,” Rogan continued. Indeed, one 2017 study found that more 80% of subjects saw their withdrawal symptoms “eliminated or drastically reduced.” The podcaster said he sent this information to Trump and recalled the president’s reply: “Sounds great. You want FDA approval, let’s do it.”
Fernandez Lynch specifically called out this account. “What Trump was saying around the executive order during the press conference was kind of mind blowing. Like this idea that his buddies could just send him a text and he’ll offer them FDA approval is not acceptable,” she said.
The focus of the signing—and the document itself—was indeed on ibogaine, a psychedelic used in some countries to treat PTSD, anxiety, addiction and other psychiatric illnesses. It has also been linked, however, to a risk of death from heart problems. The experience is also challenging for patients, involving deep introspection and unavoidable memories. But it’s the physical effects that are most concerning to Levine.
“Ibogaine is a problematic compound in terms of cardiac toxicity and a 48-hour or longer kind of waking nightmare,” he said. He speculated that the executive order was the administration’s way of making good on discussions around ibogaine without accelerating approval of a potentially dangerous drug. “It’s possible that the political interest around ibogaine extended to psychedelics more broadly, maybe particularly because of some of the inherent limitations of ibogaine.”
Deborah Mash, founder and CEO of DemeRX, acknowledged that there are “regulatory hurdles” associated with ibogaine, including long QT syndrome. However, she told BioSpace, noribogaine does not come with these same safety risks.
As for her reaction to the IND approval of DMX-1001, Mash said, “I am flipping ecstatic.”
Given the context and commentary during the announcement, however, Fernandez Lynch is concerned that Saturday’s executive order could actually have a negative effect on the perception of psychedelic therapies.
“I worry that this kind of executive order will just feed into the hype and will make people question, is this just getting approved because Joe Rogan and RFK and Trump think it’s good?” she said. “Or is it being approved because it actually is good.”