Trump Issues Executive Order to Speed Up Psychedelic Drug Approvals – Stocks Rally

TLDR

• On Saturday, President Trump signed an executive order instructing the FDA to accelerate the review process for psychedelic drugs intended for mental health disorders.
• In premarket activity, AtaiBeckley’s stock increased 28%, while Compass Pathways’ shares advanced 26%.
• The order provides Commissioner’s National Priority Vouchers to psychedelics with “breakthrough therapy” status, reducing the review period from 6–10 months to just 1–2 months.
• Ibogaine, a Schedule I drug under investigation for treating opioid addiction, receives specific mention in the order.
• A $50 million allocation for federal ibogaine research was announced by the government.

(SeaPRwire) –   On Saturday, President Trump issued an executive order mandating the FDA to expedite its evaluation of psychedelic drug therapies. The order is named “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 applies to therapies for ailments such as treatment-resistant depression, PTSD, and substance use disorders.

FDA Commissioner Marty Makary stated that approvals for certain drugs could be issued as early as this summer.

For drugs already granted “breakthrough therapy” designation, the order slashes the standard review timeline of 6–10 months to 1–2 months via the use of Commissioner’s National Priority Vouchers.

Stocks of companies focused on psychedelic medicines experienced significant gains in Monday’s premarket trading. AtaiBeckley surged 28%, Compass Pathways increased 26%, GH Research advanced 19%, Definium Therapeutics went up 15%, Cybin rose approximately 15%, and Enveric BioSciences saw a 7% gain.

COMPASS Pathways plc, CMPS

With a market capitalization of about $1.5 billion, AtaiBeckley ranks among the largest publicly traded firms in the psychedelic sector.

Psychedelic Drug Stocks Surge on White House Action

Its primary drug candidate, BPL-003, is a nasal spray aimed at treatment-resistant depression and is scheduled to begin Phase 3 trials later this quarter.

The British biotechnology company Compass Pathways is working on a synthetic psilocybin treatment known as COMP360. It is undergoing late-stage trials for treatment-resistant depression and has already received FDA Breakthrough Therapy designation.

The executive order specifically highlights ibogaine, a psychedelic compound extracted from an African shrub. It is presently listed as a Schedule I controlled substance in the U.S., indicating it is deemed to have no recognized medical application.

Ibogaine is under research as a potential therapy for opioid use disorder. The order directs regulators to facilitate its availability through the Right to Try Act, legislation signed by President Trump in 2018.

A known risk associated with ibogaine is heart damage, a safety issue that has drawn regulatory attention.

Government Funding and Analyst Reactions

President Trump announced that the government will commit $50 million to federal research on ibogaine.

Jefferies analyst Andrew Tsai described the order as an “official stamp of validation to the class,” indicating it demonstrates tangible government backing.

RBC analyst Brian Abrahams noted that the signing “is a substantial step towards diminishing regulatory risk” for psychedelic medicines.

Health Secretary Robert F. Kennedy Jr. has endorsed ibogaine publicly as an alternative therapy for depression and other mental health issues.

Legislators from both major political parties have indicated intentions to draft laws that would broaden access to psychedelic-based treatments.

FDA Commissioner Makary confirmed the agency’s readiness to act swiftly in accordance with the new directive.