President Trump signed an executive order on Saturday directing the FDA to fast-track reviews of psychedelic drugs. The order is titled “Accelerating Medical Treatments for Serious Mental Illness.”
BREAKING: President Trump announces historic reforms to accelerate access to new medical research and treatments based on psychedelic drugs.
Trump will sign an executive order directing the FDA to expedite their review of certain psychedelics already designated as breakthrough… pic.twitter.com/16QIo6Fwbt
— Fox News (@FoxNews) April 18, 2026
The directive covers treatments for conditions including treatment-resistant depression, post-traumatic stress disorder, and substance abuse disorder.
FDA Commissioner Marty Makary said decisions on some drugs could come as soon as this summer.
The order cuts the usual review timeline from 6–10 months down to 1–2 months for drugs that already hold “breakthrough therapy” designation. This is done through Commissioner’s National Priority Vouchers.
Shares of psychedelic drug companies surged in premarket trading on Monday. AtaiBeckley jumped 28%, Compass Pathways climbed 26%, GH Research gained 19%, Definium Therapeutics rose 15%, Cybin was up around 15%, and Enveric BioSciences added 7%.
AtaiBeckley has a market cap of around $1.5 billion, making it one of the largest publicly traded companies in the psychedelic drug space.
Its lead drug, BPL-003, is a nasal spray targeting treatment-resistant depression. It is set to enter Phase 3 trials later this quarter.
Compass Pathways, a British biotech, is developing a synthetic psilocybin drug called COMP360. It is in late-stage trials for treatment-resistant depression and already holds Breakthrough Therapy designation from the FDA.
The executive order specifically calls out ibogaine, a psychedelic derived from an African shrub. It is currently classified as a Schedule I controlled substance in the United States, meaning it is considered to have no accepted medical use.
Ibogaine is being studied as a treatment for opioid addiction. The order instructs regulators to provide access to it under the Right to Try Act, which Trump signed in 2018.
Ibogaine carries a well-documented risk of heart damage, which has been a concern for regulators.
Trump said the government will allocate $50 million for federal research into ibogaine.
Jefferies analyst Andrew Tsai called the order an “official stamp of validation to the class,” saying it shows government support is real.
RBC analyst Brian Abrahams said the signing “is a substantial step towards diminishing regulatory risk” for psychedelic drugs.
Health Secretary Robert F. Kennedy Jr. has publicly supported ibogaine as an alternative treatment for depression and other mental health conditions.
Lawmakers from both parties have said they plan to pursue legislation to expand access to psychedelic therapies.
FDA Commissioner Makary confirmed the agency is prepared to move quickly under the new directive.
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