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Trump announces reforms to accelerate access to psychedelic drug treatments
- On Saturday, President Donald Trump signed an executive order directing the U.S. Food and Drug Administration to fast-track reviews of breakthrough-designated psychedelic therapies and allocated $50 million in federal funding for private-sector research.
- The order responds to the mental health crisis affecting veterans, with Trump citing the "life-changing potential" of experimental treatments, following Health and Human Services Secretary Robert F. Kennedy Jr.'s criticism of the FDA's "aggressive suppression of psychedelics."
- Shares of Atai Life Sciences and Compass Pathways surged Monday as the order introduces "National Priority Vouchers," potentially cutting FDA review timelines for breakthrough-designated drugs to one or two months from six to 10 months.
- Oppenheimer analyst Jay Olson called the move a "structural inflection" that reduces development risk, while Jefferies analyst Andrew Tsai described it as an "official stamp of validation" signaling government support is "real" and "actionable."
- While the order focuses on ibogaine research, the drug remains a Schedule I substance linked to "cardiovascular toxicity." FDA Commissioner Marty Makary indicated decisions on priority vouchers could arrive this summer, with analysts monitoring potential approvals between 2027 and 2030.
372 Articles
372 Articles
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'Terrifying!' Trump's latest 'humiliation' for the presidency leaves analyst aghast
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Trump Fast-Tracks Mental Health Treatments
President Trump signed an executive order on Saturday permitting expedited reviews of psychedelic drugs for medical use. The order, “Accelerating Medical Treatments For Serious Mental Illnesses,” seeks to address mental health crises. “Despite massive Federal investment into researching potential advancements in mental health care and treatment, our medical research system has yet to produce approved therapies that promote enduring improvements …
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