FDA Fast-Tracks Psychedelic Research After Trump’s Executive Order — CMPS, HELP Stocks Gain

• The FDA stated that it will issue national priority vouchers to three companies studying psilocybin for the treatment of treatment-resistant depression and major depressive disorder, and methylone for the treatment of PTSD.
• The agency stated that it has also cleared DemeRx NB’s early-stage clinical trial of noribogaine hydrochloride for potential treatment of alcohol use disorder to proceed following an Investigational New Drug submission.
• Compass Pathways announced that it has been awarded a national priority voucher for COMP360, its proprietary formulation of synthetic psilocybin for treatment-resistant depression.

The U.S. Food and Drug Administration (FDA) on Friday announced several regulatory actions to accelerate the development of psychedelic treatments aimed at serious mental health issues.

The FDA stated that this will increase support for psychedelic-based medicines for the treatment of conditions like post-traumatic stress disorder, treatment-resistant depression, and major depressive disorder.

“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” said Health and Human Services Secretary Robert F. Kennedy, Jr.

This comes after President Trump signed an executive order last week that directed health agencies to speed up research on drugs like psilocybin, MDMA, and ibogaine.

Shares of Enveric Biosciences Inc. (ENVB) skyrocketed over 62% in Friday morning’s trade, while Compass Pathways Plc. (CMPS) and Helus Pharma Inc. (HELP) and Enveric Biosciences Inc. (ENVB) rose between 2% to 3%.

FDA To Issue National Priority Vouchers

The FDA stated that it will issue national priority vouchers to three companies studying psilocybin for the treatment of treatment-resistant depression and major depressive disorder, and methylone for the treatment of PTSD.

Compass Pathways announced that it has been awarded a national priority voucher for COMP360, its proprietary formulation of synthetic psilocybin for treatment-resistant depression.

The agency stated that it has also cleared an early-stage clinical trial of noribogaine hydrochloride for potential treatment of alcohol use disorder to proceed following an Investigational New Drug (IND) submission.

This is the first time the FDA has permitted a U.S.-based clinical study of an ibogaine derivative, enabling the developer of the novel therapy, DemeRx NB, to initiate a Phase 1 trial in a closely monitored clinical setting in the United States.

RFK Jr. said the agency will prioritize therapies with Breakthrough Therapy designation, for which early evidence shows meaningful improvement over existing options for serious mental illness.

The agency stated that its decision allows the study to proceed and does not mean the drug has been approved or found to be safe or effective. FDA added that it will continue to review data as it becomes available and support efforts to develop new treatments for alcohol use disorder and other mental health conditions.

CMPS stock is up 36% year-to-date, HELP stock is down 33%, while ENVB stock is up 77%.

The AdvisorShares Psychedelics ETF (PSIL) is up 68% over the past 12 months.

Also See: Dan Ives Compares Intel's Comeback To Rocky Balboa, Says AI Trade Is In Its Third Innings — 'You Follow The Capex, That's Where Investors Are'

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