Overview
- Trump signed the executive order Saturday directing federal health and law‑enforcement agencies to accelerate review and access for select psychedelic therapies for serious mental illness, with at least $50 million set aside to support state research programs.
- FDA Commissioner Marty Makary said the agency will issue three Commissioner’s National Priority Vouchers next week, a tool that can compress reviews to roughly one to two months, and he signaled potential decisions as soon as this summer.
- The order instructs FDA and the DEA to create a Right‑to‑Try pathway so eligible patients can seek investigational psychedelics outside trials, including ibogaine, which researchers warn can trigger dangerous heart rhythm problems.
- Justice Department and DEA officials are directed to begin rescheduling reviews after successful Phase III trials, keeping broader legal changes dependent on strong, controlled evidence, with veterans’ PTSD, TBI and addiction care cited as the policy’s core aim.
- Psychedelic drug developers rallied in premarket trading Monday following the order, with Compass Pathways, Atai/AtaiBeckley, Definium Therapeutics, GH Research, Enveric BioSciences and Cybin posting double‑digit gains in what analysts called a signal of reduced regulatory risk.