A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets.
President Donald Trump on Saturday signed an executive order to accelerate the development of and facilitate broader access to psychedelic therapies for serious mental health conditions.
The presidential decree directs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that have been granted breakthrough designation —a move that could shorten review periods for these therapies down to 1-2 months from the usual 6-12 months.
“We see the signing of this EO as a substantial step towards diminishing regulatory risk in this emerging class of therapies, enabling investor comfort,” RBC Capital Markets told investors in a Sunday note.
Trump’s directive comes amid building “skepticism as to what the regulatory pathway for psychedelic therapies” could look like, the analysts continued, pointing to a series of setbacks for the space that has left investors “somewhat cautious.” In August 2024, for instance, the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, citing concerns around selection bias and functional unblinding in its clinical trial.
When the rejection letter was published in mid-2025, Lykos founder Rick Doblin blasted the FDA’s verdict as inconsistent: “There is a changing of the goal post,” he said in September 2025, claiming that the biotech had responded to the FDA’s concerns but the responses were not taken into consideration for the decision. Since the rejection, Lykos has rebranded as Resilient Pharmaceuticals.
Earlier this year, the psychedelic space took another hit when reports circulated that Compass Pathways’ psilocybin therapy COMP360 had been in the running for a CNPV but was ultimately left out. COMP360, which the FDA has given its breakthrough therapy designation, is under review for post-traumatic stress disorder and treatment-resistant depression.
A potential go-ahead is expected in 2027 and would mark the first FDA-approved psychedelic, analysts at Jefferies told investors in a Sunday note.
“President Trump is providing an official stamp of validation to the class in the form of an executive order,” the firm said, “reassuring us that the [government’s] support of psychedelics is real/actionable.”
Shares of Compass rose 25% to $8.33 before the opening bell on Monday. Definium Therapeutics, which won breakthrough designation for it is lead asset DT120 for generalized anxiety disorder, is up around 13% to $25.73.
