President Donald Trump signed an executive order on 18 April directing the Food and Drug Administration to fast-track the review of psychedelic compounds designated as breakthrough therapies, triggering an immediate and substantial rally in the shares of British-founded biotechnology firms that lead the field in developing these treatments.
Compass Pathways and AtaiBeckley, the two most prominent publicly listed psychedelic drug developers, saw their US-listed shares rise 42% and 22% respectively on the first trading day following the order. Smaller firms also recorded sharp gains. The order, formally titled "Accelerating Medical Treatments for Serious Mental Illness," represents the most significant federal intervention in psychedelic drug policy in decades.
The central mechanism is the Commissioner's National Priority Voucher programme, which is designed to reduce FDA review timelines from the standard ten to twelve months to a target of one to two months. Psychedelic drugs that have received a Breakthrough Therapy designation and meet the programme's criteria become eligible for this accelerated process. The order also directs the FDA and the Drug Enforcement Administration to establish a pathway for eligible patients to access investigational psychedelic drugs under the Right to Try Act, including ibogaine compounds.
Ibogaine, a psychoactive substance derived from an African plant, features prominently in the order. Veterans' advocacy groups were visible at the signing ceremony, and Trump referenced a 2024 Stanford University study in which 30 special operations veterans with traumatic brain injuries experienced an 80 to 90 per cent reduction in symptoms of depression and anxiety within one month of ibogaine treatment. Podcaster Joe Rogan, a prominent advocate for ibogaine as a treatment for addiction and trauma in veterans, was also present and acknowledged by the president.
For Compass Pathways, the timing of the order is commercially significant. The company's lead drug, COMP360, a synthetic psilocybin treatment for treatment-resistant depression, is deep into Phase III clinical trials, with the first trial having already hit its primary endpoint in June 2025. The company expects to file its application with the FDA with final data anticipated in early Q3 2026. An accelerated review pathway could materially shorten the time to commercialisation, which is the primary variable driving valuations in this sector.
Legal and regulatory analysts have urged some caution about the order's practical reach. Constitutional scholars have noted that presidents cannot compel rescheduling of a controlled substance; they can request scientific and medical review by the DEA and the Department of Health and Human Services, but formal rescheduling authority rests elsewhere. The order's direction that the Attorney General initiate rescheduling reviews upon completion of Phase III trials may accelerate timelines, but does not guarantee outcomes.
Medical concerns have also not disappeared. Ibogaine carries documented cardiac risks, and the FDA has historically resisted research on the substance partly for that reason. Senior researchers have noted that ibogaine has arguably not met the basic safety requirements typically required for eligibility under the Right to Try Act, which requires completion of Phase I clinical trials. The order's specific inclusion of ibogaine has therefore drawn scrutiny from clinicians who regard the commercial and political pressure as running ahead of the safety evidence.
The divergence between US and UK regulatory approaches is now sharper than it has been at any point in recent years. In Britain, psychedelic compounds remain Class A controlled substances, and clinical research, while permitted under licence, proceeds within a framework that does not have an equivalent to the accelerated voucher mechanism introduced in the US. For firms such as Compass Pathways and AtaiBeckley, which are British in origin but listed on US exchanges, the gravitational pull of the American market is already reflected in where their primary commercial activities are oriented.
Whether the UK government responds by reviewing its own regulatory posture is a question that the life sciences sector will watch closely. The CEO of Compass Pathways described the executive order as reflecting a shift in attitudes towards psychedelics that could have a larger long-term impact beyond the immediate regulatory changes. If that shift takes hold, pressure on British regulators to provide a comparable environment for domestic development is likely to grow.
