By Mackenzie Tatananni
Just days after President Donald Trump signed an executive order fast-tracking the review of psychedelic drugs, more details emerged regarding the assets -- and companies -- that are set to benefit.
The Food and Drug Administration on Friday announced sweeping measures to support the development of psychedelic medications containing psilocybin, the ingredient in magic mushrooms, as well as methylone, a synthetic cathinone often substituted for MDMA.
As part of the announcement, the FDA said it would grant national priority vouchers to two companies probing the use of psilocybin for treatment-resistant depression (TRD). A third company received a voucher to explore methylone in patients with post-traumatic stress disorder.
The FDA didn't name the companies, leaving investors to connect the dots themselves. Compass Pathways stripped away some of that mystery: The British biotechnology firm, which already secured Breakthrough Therapy designation for its synthetic psilocybin candidate, said Friday that it was on the receiving end on one of the vouchers.
The other two companies, which have yet to publicly confirm the news, could be privately held Usona Institute and Transcend.
The companies are developing a psilocybin treatment for depression, and methylone for PTSD, respectively. Transcend's asset is set to be acquired by Japan's Otsuka Pharmaceuticals in the second half of the year.
Several companies that were in the spotlight earlier this week apparently were excluded from the latest round of progress. AtaiBeckley, one of the biggest gainers after the EO signing, tumbled 2.4% on Friday.
Cybin and Definium Therapeutics fell 2.2% and 3.4%, respectively. The AdvisorShares Psychedelics exchange-traded fund ticked down 0.1%
GH Research was bucking the trend, rising 4.3%. The company is developing a mebufotenin nasal spray for patients with TDA. The FDA has yet to mention mebufotenin by name in news releases, and only recently lifted a clinical hold on the asset in January.
With the hold removed, the company is cleared to enroll patients in upcoming studies. GH Research has indicated it is gearing up for a global Phase 3 program later this year.
Even if a company is selected for a voucher, this doesn't guarantee their assets will secure approval. Rather, the vouchers pave the way for a quicker review process, which might take weeks instead of months.
The FDA separately approved an early-stage clinical trial for noribogaine hydrochloride, a derivative of ibogaine, as a potential treatment for alcohol use disorder.
Ibogaine has been championed by online personalities like podcaster Joe Rogan, who remains a fixture in Trump's orbit. Rogan suggested earlier this week that he had influenced recent policy changes around psychedelics.
Ibogaine is classified as a Schedule I drug and carries a well-documented potential for heart damage. Noribogaine hydrochloride is being investigated as a safer, longer-acting alternative to treat opioid and alcohol addiction. Friday's announcement marks the first time such a substance has been authorized for a human trial in the U.S.
Heath and Human Services Secretary Robert F. Kennedy Jr. praised the move. "Under President Trump's leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments," Kennedy said, pointing specifically to ibogaine.
Friday's announcement follows earlier pledges by Kennedy and FDA Commissioner Marty Makary to ease access to psychedelics for medical use. Federal officials have highlighted veterans as a priority demographic for these treatments.
Write to Mackenzie Tatananni at mackenzie.tatananni@barrons.com
This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
April 24, 2026 15:59 ET (19:59 GMT)
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