Psychedelic-related stocks rallied in premarket trading on Monday following an executive order signed by President Donald Trump that aims to accelerate research into psychedelic substances and broaden patient access to those therapies.
The early sessions saw notable moves: Compass Pathways climbed more than 25% in the premarket by 05:16 ET. AtaiBeckley, Definium Therapeutics and GH Research recorded gains in the mid-teens, each jumping between 14% and 18%.
At a signing event in the Oval Office, the president framed the move as a response to the treatments' potential benefits. "In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression, including our cherished veterans," Trump said.
Alongside the executive order, the administration announced a $50 million federal investment earmarked for expanded research into ibogaine, a psychoactive compound derived from an African plant that has attracted attention for its reported promise in treating opioid addiction and post-traumatic stress disorder (PTSD).
Analysts interpreted the order as a clear policy signal. "President Trump is providing an official stamp of validation to the class in the form of an executive order, reassuring us that the FDA/HHS/White House’s support of psychedelics is real/actionable," Jefferies analyst Andrew Tsai said in a note. "With several executive branches aligned, investor mindshare should rise meaningfully ahead of potential approvals in 2027-30," they wrote.
Jefferies analysts pointed to a potential acceleration toward commercialization if the executive branch follows through on procedural changes. The note said psychedelics that have received FDA breakthrough therapy designations (BTDs) appear positioned to receive Commissioner National Priority Review Vouchers (CNPV), which could shorten the standard regulatory review window.
Specifically, the order instructs the FDA to issue priority review vouchers to psychedelic programs with BTDs. Jefferies estimated that such vouchers could compress the typical six-to-ten month review timeline to around one to two months.
The directive also instructs the FDA and the Drug Enforcement Administration to establish clearer pathways for patient access and to begin the process of rescheduling psychedelics, which are currently classified as Schedule I controlled substances. The analysts named several companies they view as potential beneficiaries of the policy changes, including AtaiBeckley, Definium Therapeutics, Helus Pharma, Compass Pathways, Otsuka and Reunion Neuroscience.
Context and market reaction
The executive order combined regulatory guidance with targeted research funding, prompting an immediate market response in firms tied to psychedelic research and development. Investors responded to the prospect of faster regulatory reviews and clearer patient access pathways, while the federal investment in ibogaine research underscored the administration's intent to support clinical investigation into novel treatments.
Whether early trading strength is sustained will depend on implementation of the order's directives by federal agencies and on subsequent regulatory milestones.