President Donald Trump signed an executive order on Saturday, April 18, 2026, titled "Accelerating Medical Treatments for Serious Mental Illness," directing the U.S. Food and Drug Administration (FDA) to fast-track reviews of psychedelic drugs for mental health conditions. The order specifically aims to expedite treatments for conditions including treatment-resistant depression, post-traumatic stress disorder (PTSD), substance abuse disorder, anxiety, and suicidal ideation.
The directive cuts the standard FDA review timeline from 6–10 months down to just 1–2 months for drugs already holding "breakthrough therapy" designation. This acceleration is facilitated through the use of Commissioner’s National Priority Vouchers. FDA Commissioner Marty Makary stated that decisions on some drugs could come as early as this summer.
The order places particular emphasis on ibogaine, a Schedule I controlled substance derived from an African shrub being studied as a treatment for opioid addiction. The order instructs regulators to provide access to ibogaine under the Right to Try Act and allocates $50 million in federal funding for research into the substance. The order also highlights the potential of psychedelic medicine to address veteran suicides, noting roughly 6,000 occur annually in the U.S.
Publicly traded psychedelic drug companies saw their stock prices surge in premarket trading on Monday following the announcement. AtaiBeckley shares jumped 28%, Compass Pathways rose 26%, GH Research gained 19%, Definium Therapeutics (DFTX) climbed over 13%, Cybin was up around 15%, and Enveric BioSciences added 7%. Definium Therapeutics hit a 52-week high of $25.63, marking a gain of over 300% in the past 12 months.
Definium's CEO, Rob Barrow, publicly praised the administration's move, highlighting the company's lead candidate, DT120—a lysergide tartrate being developed for Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD). Phase 3 data for DT120 in GAD is expected in early Q3 2026.
Analysts reacted positively to the news. Jefferies analyst Andrew Tsai called the order an "official stamp of validation to the class," while RBC analyst Brian Abrahams said it "is a substantial step towards diminishing regulatory risk" for psychedelic drugs. Wall Street maintains a Strong Buy consensus on Definium Therapeutics, with an average price target of $38.75, representing roughly 70% upside from current levels.
Health Secretary Robert F. Kennedy Jr. has publicly supported ibogaine, and lawmakers from both parties have indicated plans to pursue legislation to expand access to psychedelic therapies.
