Shares of psychedelics-related stocks climbed in early trade on Monday after US president Donald Trump signed an executive order aimed at accelerating research into psychedelic-assisted therapies and expanding patient access for certain serious mental health conditions, including post-traumatic stress disorder (PTSD) and treatment-resistant depression.
The executive order, signed by Trump on Saturday, directs the US Food and Drug Administration (FDA) Commissioner to prioritize review pathways for psychedelic drugs that have received Breakthrough Therapy designation for serious mental illnesses and meet criteria under a national voucher program designed to speed regulatory review.
The aim, the administration said, is to reduce delays in evaluating potential new therapies while maintaining safety and efficacy standards.
The order also instructs the FDA and the Drug Enforcement Administration to establish a pathway for eligible patients to access investigational psychedelic compounds, including ibogaine-based treatments, that are still under review but meet basic safety requirements under existing Right to Try provisions.
In addition, the Department of Health and Human Services is directed to allocate $50 million through the Advanced Research Projects Agency for Health to support research programs and match state-level investments in psychedelic studies for serious mental illness.
The order also calls for increased collaboration between federal agencies, the Department of Veterans Affairs, and private sector partners to expand clinical trial participation and generate additional evidence on experimental treatments.
The directive further instructs the Attorney General to review relevant psychedelic compounds for potential rescheduling following successful Phase 3 clinical trials and FDA approval, where appropriate.
"Today's order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life," Trump said as he signed an executive order. "If these turn out to be as good as people are saying, it's going to have a tremendous impact."
While psychedelic therapies remain experimental and are not yet widely approved for medical use, the executive order was broadly interpreted by market participants as a potential step toward faster regulatory review and expanded research funding. Shares of Compass Pathways (NASDAQ:CMPS) were up 36%, AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) shares added 23%, and GH Research (NASDAQ:GHRS) added 20%. Cybin Inc. (NYSE-A:CYBN, FRA:R7E) was up 4%, and Definium Therapeutics (NASDAQ:DFTX) was up 3%.